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)

Phase 4

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Biological: Pegylated Interferon alfa-2b; Drug: Ribavirin

• Registration Number: NCT00686777
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-12-12
• Results First Submitted QC: 2011-12-12
• Results First Posted: 2012-01-18
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-IFN + Ribavirin	Pegylated Interferon alfa-2b	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.
PEG-IFN + Ribavirin	Ribavirin	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation	Measured at 24 weeks after the end of treatment (at the end of follow-up)	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	From time of first treatment to Week 48	Prespecified adverse event discontinuance criteria included neutrophil count \<500 /mm3, platelet count \<50,000/mm3, and hemoglobin \<8.5 g/dL.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT	Measured at 24 weeks of treatment and at EOT (Treatment week 48)	HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.