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Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C Infection; Thrombocytopenia

Intervention: romiplostim (Biological); ribavirin (Drug); placebo (Other); PEG-interferon alfa-2a (Biological); laboratory biomarker analysis (Other)

Phase: Phase 2

Status: Suspended

Sponsored by: University of Southern California

Official(s) and/or principal investigator(s):
Howard Liebman, Principal Investigator, Affiliation: University of Southern California

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean platelet count for actively treated and placebo treated subjects

Secondary outcome:

Incidence of adverse events, including clinically significant changes in laboratory values and the incidence of antibody formation

Number of subjects in each treatment group who achieve a platelet count of greater or equal to 100,000/L

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

Changes in plasma HCV viral load during treatment with romiplostim alone

Incidence of sustained viral response achieved during treatment with anti-viral therapy in combination with romiplostim

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion

- 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

Exclusion

- 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

Locations and Contacts

USC/Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States
Additional Information

Starting date: March 2010
Last updated: July 22, 2014

Page last updated: August 23, 2015

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