Clinical trial NCT00686777: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation
timeFrame: Measured at 24 weeks after the end of treatment (at the end of follow-up)
measure: Number of Participants Discontinuing Treatment
timeFrame: From time of first treatment to Week 48
Secondary outcomes:
measure: Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT
timeFrame: Measured at 24 weeks of treatment and at EOT (Treatment week 48)
Other outcomes:
Locations:
Study officials:
References: