Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02715804




Registration number
NCT02715804
Ethics application status
Date submitted
17/03/2016
Date registered
22/03/2016
Date last updated
14/07/2020

Titles & IDs
Public title
A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Secondary ID [1] 0 0
2015-004068-13
Secondary ID [2] 0 0
HALO-109-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Ductal Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
Treatment: Drugs - Placebo
Treatment: Drugs - nab-Paclitaxel
Treatment: Drugs - Gemcitabine

Experimental: PAG: PEGPH20 + nab-Paclitaxel + Gemcitabine - Participants will receive 3.0 micrograms/kilogram (µg/kg) PEGPH20 as an intravenous (IV) infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks \[Week 4 of every cycle will be a rest week with no treatment\]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 milligrams/square meter (mg/m\^2) nab-paclitaxel as an IV infusion and 1000 mg/m\^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.

Placebo comparator: AG: Placebo + nab-Paclitaxel + Gemcitabine - Participants will receive placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks \[Week 4 of every cycle will be a rest week with no treatment\]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m\^2 nab-paclitaxel as an IV infusion and 1000 mg/m\^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.


Other interventions: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
PEGPH20 will be administered as per the dose and schedule specified in the respective arms.

Treatment: Drugs: Placebo
Matching placebo for PEGPH20

Treatment: Drugs: nab-Paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.

Treatment: Drugs: Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From the date of randomization until disease progression or death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary outcome [2] 0 0
Objective Response Rate (ORR): Percentage of Participants With Objective Response
Timepoint [2] 0 0
From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
From date of first objective response (CR or PR) until date of first disease progression (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary outcome [4] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Timepoint [4] 0 0
From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary outcome [5] 0 0
Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study
Timepoint [5] 0 0
From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary outcome [6] 0 0
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Timepoint [6] 0 0
From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary outcome [7] 0 0
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Timepoint [7] 0 0
From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

Eligibility
Key inclusion criteria
Inclusion criteria:

Participants must satisfy all the following inclusion criteria to be enrolled in the study:

1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
2. Stage IV PDA with histological or cytological confirmation of PDA.
3. Participants must be determined to be HA-high based on archived or fresh tumor core biopsy or sample obtained after the participant has documented metastatic disease. Biopsies/samples must meet the following requirements:

1. Pancreas tumor biopsies/samples obtained on or after the date that metastatic disease is documented or tumor biopsies/samples from a metastatic lesion are acceptable.
2. Tumor biopsies or samples must meet the requirements provided in the Study Laboratory Manual with regard to tumor tissue architecture. Note: cytology samples from fine needle aspirates without maintained tissue architecture or brushing biopsies are not acceptable.
3. Tumor tissue (formalin-fixed paraffin-embedded [FFPE] block preferred) must include enough tumor to make a minimum of 5-10 unstained, consecutive FFPE slides (10 slides are preferred) of 1 archival block that meet specific tissue sample requirements.
4. Radiographic confirmation of Stage IV PDA with at least 1 tumor metastasis measurable on computed tomography (CT) scan or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
5. If a participant has had adjuvant/neoadjuvant therapy and/or therapy for locally advanced disease (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of the aforementioned therapies, provided all toxicities have returned to baseline or less than or equal to (=) Grade 1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Life expectancy greater than or equal to (=) 3 months.
8. Age =18 years.
9. A negative urine or serum pregnancy test within 7 days before Cycle 1, Day 1 (C1D1; first dose of study medication) if female participant is of childbearing potential.
10. Screening clinical laboratory values as follows:

1. Total bilirubin =1.5 times upper limit of normal (ULN) (participants with Gilbert syndrome are eligible independent of bilirubin levels).
2. Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase) =2.5 times ULN, (if liver metastases are present, then =5 times ULN is allowed).
3. Serum creatinine =2.0 milligrams/deciliter (mg/dL) or calculated creatinine clearance =40 milliliters/minute (mL/min).
4. Serum albumin =2.5 grams/deciliter (g/dL).
5. Prothrombin time or international normalized ratio (INR) within normal limits (±15%), unless participant takes warfarin, in which case prothrombin time or INR result must be within therapeutic range.
6. Partial thromboplastin time (PTT) within normal limits (±15%).
7. Hemoglobin =9 g/dL (transfusion and erythropoietic agents allowed).
8. Absolute neutrophil count =1,500 cells/cubic millimeter (cells/mm^3).
9. Platelet count =100,000/mm^3.
11. For women of childbearing potential (WOCBP) and for men, agreement to use a highly effective contraceptive method from the time of screening throughout the study until 1 month (WOCBP) or 6 months (men) after administration of the last dose of any study medication. Highly effective contraceptive methods consist of prior sterilization, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), oral or injectable contraceptives, barrier methods, and/or true sexual abstinence.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Participants are ineligible for enrollment if they meet any of the following exclusion criteria:

1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.

1. Participants with superficial vein thrombosis are eligible.
2. Participants with visceral/splanchnic vein thrombosis are still eligible if, in the opinion of the Investigator, the visceral/splanchnic vein thrombosis is primarily associated with the anatomic location of the underlying disease of metastatic pancreatic cancer (there must be primary or metastatic disease in reasonable proximity to the thrombosis, and the Investigator determines that the thrombosis is due to a local tumor event and not a coagulation issue).
2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.
3. Known central nervous system involvement or brain metastases.
4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
5. History of cerebrovascular accident or transient ischemic attack.
6. Clinically significant pre-existing carotid artery disease.
7. Known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C within the past 12 months.
8. Known allergy to hyaluronidase.
9. Current use of megestrol acetate or megestrol acetate-containing drugs (use within 10 days of Day 1).
10. Contraindication to heparin as per institutional guidelines.
11. Women currently pregnant or breastfeeding.
12. Intolerance to dexamethasone.
13. History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.
14. Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect the interpretation of the results, or that may render the participant at high risk for treatment complications.
15. Immunization with a live vaccine up to 2 weeks prior to Day 1.
16. Hypersensitivity to the active substance or ingredients of PEGPH20, gemcitabine, and nab-paclitaxel.
17. Inability to comply with study and follow-up procedures as judged by the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/11/2019
Sample size
Target
Accrual to date
Final
492
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford
Recruitment hospital [6] 0 0
Bendigo Health Care Group - Bendigo
Recruitment hospital [7] 0 0
Monash Health - Bentleigh East
Recruitment hospital [8] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- St Leonards
Recruitment postcode(s) [5] 0 0
- Bedford
Recruitment postcode(s) [6] 0 0
- Bendigo
Recruitment postcode(s) [7] 0 0
- Bentleigh East
Recruitment postcode(s) [8] 0 0
- Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New Hampshire
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Belgium
State/province [30] 0 0
Antwerpen
Country [31] 0 0
Belgium
State/province [31] 0 0
Brussels Capital Region
Country [32] 0 0
Belgium
State/province [32] 0 0
Oost-Vlaanderen
Country [33] 0 0
Belgium
State/province [33] 0 0
Vlaams Brabant
Country [34] 0 0
Belgium
State/province [34] 0 0
Liege
Country [35] 0 0
Brazil
State/province [35] 0 0
Minas Gerais
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio Grande Do Sul
Country [37] 0 0
Brazil
State/province [37] 0 0
São Paulo
Country [38] 0 0
Brazil
State/province [38] 0 0
Barretos
Country [39] 0 0
Brazil
State/province [39] 0 0
Rio de Janeiro
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Croatia
State/province [41] 0 0
Grad Zagreb
Country [42] 0 0
Croatia
State/province [42] 0 0
Zagreb
Country [43] 0 0
Czechia
State/province [43] 0 0
Brno-mesto
Country [44] 0 0
Czechia
State/province [44] 0 0
Královéhradecký Kraj
Country [45] 0 0
Czechia
State/province [45] 0 0
Olomoucký Kraj
Country [46] 0 0
Czechia
State/province [46] 0 0
Prague
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 5
Country [48] 0 0
Denmark
State/province [48] 0 0
South Denmark
Country [49] 0 0
Estonia
State/province [49] 0 0
Harjumaa
Country [50] 0 0
France
State/province [50] 0 0
Bretagne
Country [51] 0 0
France
State/province [51] 0 0
Franche-Comté
Country [52] 0 0
France
State/province [52] 0 0
Hérault
Country [53] 0 0
France
State/province [53] 0 0
Loire-Atlantique
Country [54] 0 0
France
State/province [54] 0 0
Puy-de-Dôme
Country [55] 0 0
France
State/province [55] 0 0
Rhône
Country [56] 0 0
France
State/province [56] 0 0
Val-de-Marne
Country [57] 0 0
France
State/province [57] 0 0
Angers Cedex 02
Country [58] 0 0
France
State/province [58] 0 0
Bordeaux
Country [59] 0 0
France
State/province [59] 0 0
Créteil
Country [60] 0 0
France
State/province [60] 0 0
Lyon Cedex
Country [61] 0 0
France
State/province [61] 0 0
Lyon
Country [62] 0 0
France
State/province [62] 0 0
Paris
Country [63] 0 0
France
State/province [63] 0 0
Île-de-France
Country [64] 0 0
Germany
State/province [64] 0 0
Baden-Württemberg
Country [65] 0 0
Germany
State/province [65] 0 0
Bayern
Country [66] 0 0
Germany
State/province [66] 0 0
Nordrhein-Westfalen
Country [67] 0 0
Germany
State/province [67] 0 0
Sachsen
Country [68] 0 0
Germany
State/province [68] 0 0
Berlin
Country [69] 0 0
Germany
State/province [69] 0 0
Essen
Country [70] 0 0
Germany
State/province [70] 0 0
Halle
Country [71] 0 0
Germany
State/province [71] 0 0
Hamburg
Country [72] 0 0
Germany
State/province [72] 0 0
Heidelberg
Country [73] 0 0
Hungary
State/province [73] 0 0
Baranya
Country [74] 0 0
Hungary
State/province [74] 0 0
Csongrád
Country [75] 0 0
Hungary
State/province [75] 0 0
Gyor-Moson-Sopron
Country [76] 0 0
Hungary
State/province [76] 0 0
Hajdú-Bihar
Country [77] 0 0
Hungary
State/province [77] 0 0
Budapest
Country [78] 0 0
Hungary
State/province [78] 0 0
Kaposvár
Country [79] 0 0
Israel
State/province [79] 0 0
HaMerkaz
Country [80] 0 0
Israel
State/province [80] 0 0
Tel-Aviv
Country [81] 0 0
Israel
State/province [81] 0 0
Yerushalayim
Country [82] 0 0
Israel
State/province [82] 0 0
Afula
Country [83] 0 0
Israel
State/province [83] 0 0
Beer Sheva
Country [84] 0 0
Israel
State/province [84] 0 0
Hadera
Country [85] 0 0
Israel
State/province [85] 0 0
Haifa
Country [86] 0 0
Israel
State/province [86] 0 0
Jerusalem
Country [87] 0 0
Israel
State/province [87] 0 0
Tel Hashomer
Country [88] 0 0
Italy
State/province [88] 0 0
Foggia
Country [89] 0 0
Italy
State/province [89] 0 0
Milano
Country [90] 0 0
Italy
State/province [90] 0 0
Cremona
Country [91] 0 0
Italy
State/province [91] 0 0
Genova
Country [92] 0 0
Italy
State/province [92] 0 0
Milan
Country [93] 0 0
Italy
State/province [93] 0 0
Padova
Country [94] 0 0
Italy
State/province [94] 0 0
Roma
Country [95] 0 0
Italy
State/province [95] 0 0
Verona
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Busan Gwang'yeogsi
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Daegu Gwang'yeogsi
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Gyeonggido
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Seoul Teugbyeolsi
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Incheon
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Seoul
Country [102] 0 0
Latvia
State/province [102] 0 0
Daugavpils
Country [103] 0 0
Latvia
State/province [103] 0 0
Riga
Country [104] 0 0
Lithuania
State/province [104] 0 0
Vilniaus Apskritis
Country [105] 0 0
Netherlands
State/province [105] 0 0
Limburg
Country [106] 0 0
Netherlands
State/province [106] 0 0
Amsterdam
Country [107] 0 0
Netherlands
State/province [107] 0 0
Hoofddorp
Country [108] 0 0
Netherlands
State/province [108] 0 0
Nijmegen
Country [109] 0 0
Poland
State/province [109] 0 0
Podkarpackie
Country [110] 0 0
Poland
State/province [110] 0 0
Lublin
Country [111] 0 0
Poland
State/province [111] 0 0
Warszawa
Country [112] 0 0
Spain
State/province [112] 0 0
Barcelona
Country [113] 0 0
Spain
State/province [113] 0 0
Madrid
Country [114] 0 0
Spain
State/province [114] 0 0
Navarra
Country [115] 0 0
Spain
State/province [115] 0 0
Valencia
Country [116] 0 0
Spain
State/province [116] 0 0
Zaragoza
Country [117] 0 0
Taiwan
State/province [117] 0 0
Taichung Municipality
Country [118] 0 0
Taiwan
State/province [118] 0 0
Changhua
Country [119] 0 0
Taiwan
State/province [119] 0 0
Tainan
Country [120] 0 0
Taiwan
State/province [120] 0 0
Taipei
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Cambridgeshire
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Glasgow City
Country [123] 0 0
United Kingdom
State/province [123] 0 0
London, City Of
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Midlothian
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Wirral
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Birmingham
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Cottingham
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Coventry
Country [129] 0 0
United Kingdom
State/province [129] 0 0
London
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Rhyl
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Withington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Halozyme Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
VP, Medical, Regulatory and Drug Safety
Address 0 0
Halozyme Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02715804