Study Stopped
Approval of several new agents for the treatment of HCV infection would mitigate the future need for interferon HCV treatment
Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia
A Double-Blind, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Romiplostim, Administered Once Weekly to Thrombocytopenic Hepatitis C (HCV) Infected Subjects Who Are Not Candidates for Antiviral Treatment With Pegylated Interferon and Ribavirin Due to Persistent Thrombocytopenia
2 other identifiers
interventional
27
1 country
1
Brief Summary
RATIONALE: Romiplostim may cause the body to make platelets. PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating hepatitis C-infected patients with thrombocytopenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 2010
CompletedStudy Start
First participant enrolled
June 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2018
CompletedApril 11, 2017
April 1, 2017
4 years
June 24, 2010
April 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Mean platelet count for actively treated and placebo treated subjects
Weeks 6-8
Secondary Outcomes (5)
Incidence of adverse events, including clinically significant changes in laboratory values and the incidence of antibody formation
Weeks 1-24
Number of subjects in each treatment group who achieve a platelet count of greater or equal to 100,000/L
Week 8
Number of patients originally receiving active treatment who maintain a platelet count > 50,000/L while receiving anti-viral therapy with pegylated interferon and ribavirin
Weeks 9-24
Changes in plasma HCV viral load during treatment with romiplostim alone
Weeks 1-8
Incidence of sustained viral response achieved during treatment with anti-viral therapy in combination with romiplostim
Weeks 9-24
Study Arms (2)
Arm I
ACTIVE COMPARATORPatients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
Arm II
PLACEBO COMPARATORPatients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of \> 100,000/L cross over to arm I.
Interventions
Given subcutaneously
Given orally
Given subcutaneously
Eligibility Criteria
You may qualify if:
- All patients with HCV virus infection documented by detectable plasma HCV antibodies and RNA who would be excluded by FDA criteria for antiviral treatment with peginterferon-alpha 2a and ribavirin due to thrombocytopenia (platelets \< 70,000/L); patients cannot have received previous anti-viral therapy with interferon/ribavirin
- Liver biopsy indicating chronic hepatitis within the previous 2 years
- Mean platelet count of \< 70,000/L on two repeated measurements in a two week screening period with no single count \>= 75,000/L
- Neutrophil count of \>= 1000/mcl
- Hemoglobin \>= 11gm/dL and no evidence of active bleeding
- Prothrombin Time (PT) INR \< 1.6 seconds
- Albumin \>= 2.5 gm/dL
- ALT \>= 1.2 and \< 10 times upper limit of normal
- No evidence of either ischemic change or cardiac injury on 12-lead electrocardiogram (EKG)
- Negative pregnancy test and women must be using adequate contraception for at least 2 weeks prior to enrollment and while enrolled in the study
- Signed informed consent within 2 weeks of enrollment and randomization
You may not qualify if:
- Received previous anti-viral therapy with interferon/ribavirin
- Child's Class B and C or acute decompensated liver disease
- Human Immunodeficiency Virus (HIV) infection or co-infected with hepatitis B virus
- Any untreated active infection
- Active malignancy, known primary bone marrow disorder (myelodysplasia, myeloproliferative disease, etc.), or history of blood or bone marrow transplantation; patients with documented hemoglobinopathies
- Active vasculitis associated with cryoglobulinemia as manifested by either renal disease or dermatologic findings
- Positive pregnancy test or men with pregnant partners
- Creatinine and BUN of greater than twice (2x) the upper limits of normal
- History of venous or arterial thrombosis, myocardial infarction or thrombotic stroke
- Patients who in the investigators opinion will fail to be compliant or have other contraindication to treatment on this study
- Other inherited or acquired liver disease
- Previous solid organ transplant
- Known hypersensitivity to E. coli derived recombinant proteins
- Active rheumatologic disease including Systemic Lupus Erythematosis
- Known history of Disseminated Intravascular Coagulation, Hemolytic Uremic Syndrome, or Thrombotic Thrombocytopenic Purpura
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Liebman
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2010
First Posted
June 30, 2010
Study Start
June 30, 2010
Primary Completion
July 14, 2014
Study Completion
July 14, 2018
Last Updated
April 11, 2017
Record last verified: 2017-04