Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

Phase 2

Terminated

• Conditions: Hepatitis C Infection; Thrombocytopenia
• Interventions: Biological: romiplostim; Drug: ribavirin; Other: placebo; Biological: PEG-interferon alfa-2a; Other: laboratory biomarker analysis

• Registration Number: NCT01153919
• Lead Sponsor: University of Southern California

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the platelet count response to administration of weekly romiplostim patients with HCV infection whose initial platelet count is \< 70,000/L.

SECONDARY OBJECTIVES:

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 Timeline

• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-28
• Study Start: 2010-06-30
• Study First Posted: 2010-06-30
• Primary Completion: 2014-07-14
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-09
• Last Update Posted: 2017-04-11
• Study Completion: 2018-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm II	laboratory biomarker analysis	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.
Arm I	PEG-interferon alfa-2a	Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
Arm I	romiplostim	Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
Arm I	ribavirin	Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
Arm I	laboratory biomarker analysis	Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
Arm II	ribavirin	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.
Arm II	placebo	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.
Arm II	PEG-interferon alfa-2a	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.

Primary Outcome Measures

Name	Time	Method
Mean platelet count for actively treated and placebo treated subjects	Weeks 6-8

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States