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: October 22, 2013
Last verified: October 2013
  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
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: October 22, 2013
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
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on April 17, 2014