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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00686777
First received: May 27, 2008
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Biological: Pegylated Interferon alfa-2b
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation [ Time Frame: Measured at 24 weeks after the end of treatment (at the end of follow-up) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From time of first treatment to Week 48 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Measured at 24 weeks of treatment and at EOT (Treatment week 48) ] [ Designated as safety issue: No ]
    HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.


Enrollment: 75
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-IFN + 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.
Biological: Pegylated Interferon alfa-2b
Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks
Other Name: SCH 54031
Drug: Ribavirin
Ribavirin 400 mg/day orally
Other Name: SCH 18908

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686777     History of Changes
Other Study ID Numbers: P05172, JPC-06-320-40
Study First Received: May 27, 2008
Results First Received: December 12, 2011
Last Updated: April 29, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
hepatitis C

Additional relevant MeSH terms:
Body Weight
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Signs and Symptoms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferons
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014