Back to resultsPegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pegylated Interferon alfa-2b
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with chronic hepatitis C.
- Minimum 20 years of age
- Willing to use adequate contraception during the course of the study.
- Participants who can be hospitalized for at least 14 days since treatment initiation.
- Positive for HCV genotype 1 (genotype 1a and 1b) with high viral load (HCV-RNA >=100 kIU/mL).
- Participants weighing over 40 kg to 50 kg.
Hematology results of:
- hemoglobin levels >=12 g/dL
- neutrophils >=1,500/mm^3
- platelets >=100,000/mm^3
Exclusion Criteria:
- Previous ribavirin therapy.
- Previous interferon therapy within 90 days of registration.
- Participants who received treatment with injectable products containing glycyrrhizin/cysteine/glycine (Stronger Neo-Minophagen C, etc.), Shosaikoto, or ursodeoxycholic acid within 30 days before the start of treatment
- Participants who received treatment with an antiviral or anti-tumor drug or who received immunomodulating therapy (including steroids and radiotherapy) within 90 days before the start of treatment [excluding local administration and topical drugs].
- Participants who received other investigational drugs within 180 days before the start of treatment.
- Hepatitis Bs (HBs) antigen-positive
- Antinuclear antibodies >=1:160
- Fasting blood glucose >=110 mg/dL (however, participants with fasting blood glucose of 110 mg/dL to <126 mg/dL can be registered if HbA1c is <6.5%)
- Participants diagnosed with liver cirrhosis in most recent celioscopy or liver biopsy.
- Participants with or who have a history of any of the following: liver failure; hepatic encephalopathy, esophageal varices, or ascites; depression or schizophrenia requiring treatment or suicidal attempt or ideation; epileptic seizures requiring drug treatment; autoimmune disease (such as Hashimoto's disease, Crohn's disease, ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic erythematosus, autoimmune hemolytic anemia, and scleroderma); hepatic cancer
- Participants with any of the following: liver disease such as autoimmune hepatitis, alcoholic liver disease, and drug-induced hepatic impairment; hemophilia; arrhythmia requiring treatment and participants with or who have a history of angina pectoris, cardiac failure, myocardial infarction, or life-threatening arrhythmia; hypertension (systolic BP of 160 mmHg or more and diastolic BP of 100 mmHg or more) not possible to control with drug therapy; chronic pulmonary disease; hemoglobinopathy (thalassemia, sickle cell anemia); malignant tumor or who have a history of malignant tumor within the past 5 years; thyroid function disorder not controlled by drug therapy.
- Participants with organ transplants (excluding cornea and hair transplants).
- Participants with a history of hypersensitivity to interferon preparations, nucleoside analogs, or biological products such as vaccine.
- Participants with a specific response to PEG-IFN alfa-2b in a prick test to be conducted just before the initiation of treatment.
- Participants who are pregnant or nursing (in the case of male Participants : partner is pregnant)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG-IFN + Ribavirin
Arm Description
Pegylated Interferon alfa-2b was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation
SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.
HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result.
Number of Participants Discontinuing Treatment
Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.
Secondary Outcome Measures
Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT
HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00686777
Brief Title
Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)
Official Title
Low Dose Treatment of Ribavirin in Combination With PEG-IFN Alfa-2b in CHC Patients With genotype1 High Viral Load and Low Body Weight
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to evaluate the efficacy and safety of the combination therapy with subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-IFN + Ribavirin
Arm Type
Experimental
Arm Description
Pegylated Interferon alfa-2b was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Intervention Type
Biological
Intervention Name(s)
Pegylated Interferon alfa-2b
Other Intervention Name(s)
SCH 54031
Intervention Description
Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
SCH 18908
Intervention Description
Ribavirin 400 mg/day orally
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation
Description
SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.
HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result.
Time Frame
Measured at 24 weeks after the end of treatment (at the end of follow-up)
Title
Number of Participants Discontinuing Treatment
Description
Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.
Time Frame
From time of first treatment to Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT
Description
HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.
Time Frame
Measured at 24 weeks of treatment and at EOT (Treatment week 48)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with chronic hepatitis C.
Minimum 20 years of age
Willing to use adequate contraception during the course of the study.
Participants who can be hospitalized for at least 14 days since treatment initiation.
Positive for HCV genotype 1 (genotype 1a and 1b) with high viral load (HCV-RNA >=100 kIU/mL).
Participants weighing over 40 kg to 50 kg.
Hematology results of:
hemoglobin levels >=12 g/dL
neutrophils >=1,500/mm^3
platelets >=100,000/mm^3
Exclusion Criteria:
Previous ribavirin therapy.
Previous interferon therapy within 90 days of registration.
Participants who received treatment with injectable products containing glycyrrhizin/cysteine/glycine (Stronger Neo-Minophagen C, etc.), Shosaikoto, or ursodeoxycholic acid within 30 days before the start of treatment
Participants who received treatment with an antiviral or anti-tumor drug or who received immunomodulating therapy (including steroids and radiotherapy) within 90 days before the start of treatment [excluding local administration and topical drugs].
Participants who received other investigational drugs within 180 days before the start of treatment.
Hepatitis Bs (HBs) antigen-positive
Antinuclear antibodies >=1:160
Fasting blood glucose >=110 mg/dL (however, participants with fasting blood glucose of 110 mg/dL to <126 mg/dL can be registered if HbA1c is <6.5%)
Participants diagnosed with liver cirrhosis in most recent celioscopy or liver biopsy.
Participants with or who have a history of any of the following: liver failure; hepatic encephalopathy, esophageal varices, or ascites; depression or schizophrenia requiring treatment or suicidal attempt or ideation; epileptic seizures requiring drug treatment; autoimmune disease (such as Hashimoto's disease, Crohn's disease, ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic erythematosus, autoimmune hemolytic anemia, and scleroderma); hepatic cancer
Participants with any of the following: liver disease such as autoimmune hepatitis, alcoholic liver disease, and drug-induced hepatic impairment; hemophilia; arrhythmia requiring treatment and participants with or who have a history of angina pectoris, cardiac failure, myocardial infarction, or life-threatening arrhythmia; hypertension (systolic BP of 160 mmHg or more and diastolic BP of 100 mmHg or more) not possible to control with drug therapy; chronic pulmonary disease; hemoglobinopathy (thalassemia, sickle cell anemia); malignant tumor or who have a history of malignant tumor within the past 5 years; thyroid function disorder not controlled by drug therapy.
Participants with organ transplants (excluding cornea and hair transplants).
Participants with a history of hypersensitivity to interferon preparations, nucleoside analogs, or biological products such as vaccine.
Participants with a specific response to PEG-IFN alfa-2b in a prick test to be conducted just before the initiation of treatment.
Participants who are pregnant or nursing (in the case of male Participants : partner is pregnant)
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)
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