Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia
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|ClinicalTrials.gov Identifier: NCT01153919|
Recruitment Status : Terminated (Approval of several new agents for the treatment of HCV infection would mitigate the future need for interferon HCV treatment)
First Posted : June 30, 2010
Last Update Posted : April 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Infection Thrombocytopenia||Biological: romiplostim Drug: ribavirin Other: placebo Biological: PEG-interferon alfa-2a Other: laboratory biomarker analysis||Phase 2|
I. To assess the platelet count response to administration of weekly romiplostim patients with HCV infection whose initial platelet count is < 70,000/L.
I. To assess the safety and tolerability of romiplostim the treatment of patients with HCV infection and thrombocytopenia; including physical symptoms and findings, hematologic, serum chemistries and liver function tests and adverse events.
II. To assess the ability of romiplostim to enable subjects to achieve a platelet count sufficient to start antiviral therapy.
III. To assess the ability of romiplostim to maintain platelet counts greater than 50,000/L while receiving antiviral therapy with pegylated interferon and ribavirin.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of > 100,000/L cross over to arm I.
Patients achieving a platelet count of > 100,000/L at 8 weeks receive PEG-interferon alfa-2a subcutaneously once weekly and oral ribavirin once daily. Treatment repeats every 7 days for 24-48 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 and 36 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||June 30, 2010|
|Actual Primary Completion Date :||July 14, 2014|
|Estimated Study Completion Date :||July 14, 2018|
Active Comparator: Arm I
Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: ribavirin
Other Names:Biological: PEG-interferon alfa-2a
Other Names:Other: laboratory biomarker analysis
Placebo Comparator: Arm II
Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of > 100,000/L cross over to arm I.
Other Names:Other: placebo
Other Name: PLCBBiological: PEG-interferon alfa-2a
Other Names:Other: laboratory biomarker analysis
- Mean platelet count for actively treated and placebo treated subjects [ Time Frame: Weeks 6-8 ]
- Incidence of adverse events, including clinically significant changes in laboratory values and the incidence of antibody formation [ Time Frame: Weeks 1-24 ]
- Number of subjects in each treatment group who achieve a platelet count of greater or equal to 100,000/L [ Time Frame: 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 [ Time Frame: Weeks 9-24 ]
- Changes in plasma HCV viral load during treatment with romiplostim alone [ Time Frame: Weeks 1-8 ]
- Incidence of sustained viral response achieved during treatment with anti-viral therapy in combination with romiplostim [ Time Frame: Weeks 9-24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153919
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Howard Liebman||University of Southern California|