Hepatitis C InfectionPhase 2NCT01153919
Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia
A Phase 2 study testing romiplostim, ribavirin and PEG-interferon alfa-2a in people with Hepatitis C Infection and Thrombocytopenia, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Infection, Thrombocytopenia
- What is being tested?
- romiplostim, ribavirin and PEG-interferon alfa-2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2010to 14 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Hepatitis C Infection, Thrombocytopenia
- Being tested
- romiplostim, ribavirin, placebo, PEG-interferon alfa-2a, laboratory biomarker analysis
- Medical subject headings
- Hepatitis C, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
romiplostimBiological
Also called AMG 531, Amgen megakaryopoiesis protein 2, Nplate
Given subcutaneously
ribavirinDrug
Also called ICN-1229, Rebetol, RIBA, RTCA
Given orally
placeboOther
Also called PLCB
Given subcutaneously
PEG-interferon alfa-2aBiological
Also called PEG-IFNA2a, PEGASYS, pegylated interferon alfa-2a
Given subcutaneously
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity. Receives: Biological: romiplostim; Drug: ribavirin; Biological: PEG-interferon alfa-2a; Other: laboratory biomarker analysis |
| Arm II | Placebo comparator | 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. Receives: Drug: ribavirin; Other: placebo; Biological: PEG-interferon alfa-2a; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean platelet count for actively treated and placebo treated subjects
Measured: Weeks 6-8
Secondary outcomes (5)
Incidence of adverse events, including clinically significant changes in laboratory values and the incidence of antibody formation
Measured: Weeks 1-24
Number of subjects in each treatment group who achieve a platelet count of greater or equal to 100,000/L
Measured: 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
Measured: Weeks 9-24
Changes in plasma HCV viral load during treatment with romiplostim alone
Measured: Weeks 1-8
Incidence of sustained viral response achieved during treatment with anti-viral therapy in combination with romiplostim
Measured: Weeks 9-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study start30 Jun 2010
- Primary completion14 Jul 2014
- Study completion14 Jul 2018 (estimated)
Why it stopped: Approval of several new agents for the treatment of HCV infection would mitigate the future need for interferon HCV treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C InfectionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Liebman, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153919
- Sponsor's protocol ID
- NC-HEM-07-5
- Other IDs
- NCI-2010-00358
- Status last verified
- Apr 2017
- First submitted
- 24 Jun 2010
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01153919
- Acronym / sponsor ID
- NC-HEM-07-5
- Conditions
- Hepatitis C Infection, Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Approval of several new agents for the treatment of HCV infection would mitigate the future need for interferon HCV treatment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 30 Jun 2010 (actual)
- Primary completion
- 14 Jul 2014 (actual)
- Study completion
- 14 Jul 2018 (estimated)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Biological: romiplostim, Drug: ribavirin, Biological: PEG-interferon alfa-2a, Other: laboratory biomarker analysisPatients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity. |
| Arm II | Placebo comparator | Drug: ribavirin, Other: placebo, Biological: PEG-interferon alfa-2a, Other: laboratory biomarker analysisPatients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of \> 100,000/L cross over to arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| romiplostimAlso: AMG 531, Amgen megakaryopoiesis protein 2, NplateGiven subcutaneously | Biological | Arm I |
| ribavirinAlso: ICN-1229, Rebetol, RIBA, RTCAGiven orally | Drug | Arm I, Arm II |
| placeboAlso: PLCBGiven subcutaneously | Other | Arm II |
| PEG-interferon alfa-2aAlso: PEG-IFNA2a, PEGASYS, pegylated interferon alfa-2aGiven subcutaneously | Biological | Arm I, Arm II |
| laboratory biomarker analysisCorrelative studies | Other | Arm I, Arm II |
Primary outcome
Mean platelet count for actively treated and placebo treated subjects
Time frame: Weeks 6-8
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Approval of several new agents for the treatment of HCV infection would mitigate the future need for interferon HCV treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Liebman principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing romiplostim, ribavirin and PEG-interferon alfa-2a in people with Hepatitis C Infection and Thrombocytopenia, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Approval of several new agents for the treatment of HCV infection would mitigate the future need for interferon HCV treatment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean platelet count for actively treated and placebo treated subjects (time frame: Weeks 6-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.