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Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

Primary Purpose

Hepatitis C Infection, Thrombocytopenia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
romiplostim
ribavirin
placebo
PEG-interferon alfa-2a
laboratory biomarker analysis
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of &gt; 100,000/L cross over to arm I.

Outcomes

Primary Outcome Measures

Mean platelet count for actively treated and placebo treated subjects

Secondary Outcome Measures

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 &gt; 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

Full Information

First Posted
June 24, 2010
Last Updated
April 9, 2017
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT01153919
Brief Title
Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Approval of several new agents for the treatment of HCV infection would mitigate the future need for interferon HCV treatment
Study Start Date
June 30, 2010 (Actual)
Primary Completion Date
July 14, 2014 (Actual)
Study Completion Date
July 14, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Infection, Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of &gt; 100,000/L cross over to arm I.
Intervention Type
Biological
Intervention Name(s)
romiplostim
Other Intervention Name(s)
AMG 531, Amgen megakaryopoiesis protein 2, Nplate
Intervention Description
Given subcutaneously
Intervention Type
Drug
Intervention Name(s)
ribavirin
Other Intervention Name(s)
ICN-1229, Rebetol, RIBA, RTCA, Viramide, Virazole
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given subcutaneously
Intervention Type
Biological
Intervention Name(s)
PEG-interferon alfa-2a
Other Intervention Name(s)
PEG-IFNA2a, PEGASYS, pegylated interferon alfa-2a
Intervention Description
Given subcutaneously
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Mean platelet count for actively treated and placebo treated subjects
Time Frame
Weeks 6-8
Secondary Outcome Measure Information:
Title
Incidence of adverse events, including clinically significant changes in laboratory values and the incidence of antibody formation
Time Frame
Weeks 1-24
Title
Number of subjects in each treatment group who achieve a platelet count of greater or equal to 100,000/L
Time Frame
Week 8
Title
Number of patients originally receiving active treatment who maintain a platelet count &gt; 50,000/L while receiving anti-viral therapy with pegylated interferon and ribavirin
Time Frame
Weeks 9-24
Title
Changes in plasma HCV viral load during treatment with romiplostim alone
Time Frame
Weeks 1-8
Title
Incidence of sustained viral response achieved during treatment with anti-viral therapy in combination with romiplostim
Time Frame
Weeks 9-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Liebman
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

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