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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01966419




Registration number
NCT01966419
Ethics application status
Date submitted
11/10/2013
Date registered
21/10/2013

Titles & IDs
Public title
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
Scientific title
Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Associated Hyperammonemia With an Episode of Hepatic Encephalopathy (STOP-HE Study)
Secondary ID [1] 0 0
2013-005412-10
Secondary ID [2] 0 0
OCR002-HE209
Universal Trial Number (UTN)
Trial acronym
STOP-HE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Episode of Overt Hepatic Encephalopathy 0 0
Hepatic Encephalopathy 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ornithine phenylacetate
Treatment: Drugs - placebo intravenous infusion

Active comparator: Ornithine phenylacetate - Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)

Placebo comparator: Placebo - Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC


Treatment: Drugs: ornithine phenylacetate
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation

Treatment: Drugs: placebo intravenous infusion
Placebo for continuous IV infusion that is visually identical to the experimental product
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Each HE Stage
Timepoint [1] 0 0
Baseline to End of Study (through 3 hours post end-of-infusion)

Eligibility
Key inclusion criteria
* Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
* Elevated venous ammonia
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Renal failure with serum creatinine > 3 mg/dL or need for dialysis
* Molecular Adsorbent Recirculation System utilized
* Pregnancy or breastfeeding

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/12/2016
Sample size
Target
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Kingswood
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Bedford Park
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
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Arkansas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ocera Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Team Leader
Address 0 0
Ocera Therapeutics, Inc.
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT01966419) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at [email protected].


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01966419