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)

NCT00686777 | Completed Phase 4 Results

• 2 other identifiers: P05172JPC-06-320-40
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic

Keywords

hepatitis C

Outcome Measures

Primary Outcomes (2)

• 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.

  Measured at 24 weeks after the end of treatment (at the end of follow-up)

• 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.

  From time of first treatment to Week 48

Secondary Outcomes (1)

• 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)

Study Arms (1)

PEG-IFN + Ribavirin

EXPERIMENTAL

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.

Biological: Pegylated Interferon alfa-2b; Drug: Ribavirin

Interventions

Pegylated Interferon alfa-2b BIOLOGICAL

Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks

Also known as: SCH 54031

PEG-IFN + Ribavirin

Ribavirin DRUG

Ribavirin 400 mg/day orally

Also known as: SCH 18908

PEG-IFN + Ribavirin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 7, 2017
• Results First Posted: January 18, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share