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Trial record 22 of 538 for:    IFNA2 AND RBV AND Hepatitis

Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378599
Recruitment Status : Completed
First Posted : September 20, 2006
Results First Posted : July 16, 2010
Last Update Posted : April 6, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence.

Condition or disease Intervention/treatment Phase
Liver Transplantation Hepatitis C, Chronic Liver Cirrhosis Drug: Combination of (a) pegylated interferon alfa-2b and (b) rebetol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROTECT - Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation: Efficacy and Safety in Hepatitis C Recurrence Therapy
Study Start Date : May 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: PEG-Intron plus Rebetol (RBV)
PEG-Intron plus RBV treatment for up to 48 weeks with 24-week follow up. SCH 54031 PEG-Intron 1.5 ug/kg SC per week plus SCH 18908 REBETOL twice daily (BID) PO with food, dosed as followed: Weeks 1 and 2, RBV Dose 400 mg (2 capsules, 1 AM and 1 PM). At the end of Weeks 2 and 4 of Treatment (tx), a complete blood count (CBC) was performed. An increase in RBV dose was permitted only if the hemoglobin was >10 g/dL. At Weeks 3 and 4, RBV dose was 800 mg (4 capsules, 2 AM and 2 PM). From Weeks 5 to 48, RBV doses could be increased based on subject body weight. For subjects weighing <65 kg, maximum dose of RBV was to be 800 mg (4 capsules, 2 AM and 2 PM), for subjects weighing 65-85 kg, max dose of RBV was 1000 mg/day (5 capsules, 2 AM and 3 PM), for subjects weighing >85 kg, max dose of RBV was 1200 mg/day, 6 capsules, 3 AM and 3 PM).
Drug: Combination of (a) pegylated interferon alfa-2b and (b) rebetol
  1. Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
  2. 200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks
Other Names:
  • (a) SCH 54031, PEG-Intron
  • (b) SCH 18908, Rebetol

Primary Outcome Measures :
  1. A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment [ Time Frame: 24 weeks after completion of up to 48 weeks of therapy ]
    Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must confirm that all prior medication washout times have been observed.
  • Subject must be 18 - 70 years of age of either gender and of any race.
  • Subject must be transplanted for end-stage hepatitis C or fulminant hepatitis C.
  • Subject must have documented:

    • persistent HCV viremia after OLT as defined by plasma positive for HCV RNA by quantitative reverse transcription-polymerase chain reaction (RT-PCR),
    • A liver transplant performed at least 3 months prior to screening but not more than 3 years prior to screening.
  • Subject must be on stable doses of immunosuppression for at least 1 month.
  • Compensated liver disease with minimum hematologic, biochemical, and serologic criteria at the (Day 1) baseline visit.

    • Alpha-fetoprotein value (AFP) less than or equal to 250ng/mL. If AFP greater than 100 ng/mL, patient will need evidence of normal liver (magnetic resonance imaging) MRI and normal chest computerized tomography (CT) scan within the last 3 months or during the screening period.
  • For subjects with a history of diabetes or hypertension, clearance from an ophthalmologist has to be obtained prior to treatment start (Day 1/Visit 2).
  • Subjects with a history of mild depression may be considered for entry into this study.
  • Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control.
  • Sexually active male subjects are practicing an acceptable, method of contraception.
  • Contraceptive measures will be reviewed with female subjects at each visit. Dual methods of contraception must be used for 1 month prior to the start of treatment and 6 months after treatment discontinuation.
  • Pregnancy tests obtained at Screen Visit and Day 1 Visit prior to the initiation of treatment must be negative.

Exclusion Criteria:

  • Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women (during study and up to 6 months after study completion).
  • Subject has used any investigational product within 30 days prior to Screening or is participating in any other clinical study.
  • Prior treatment for chronic hepatitis C post-liver transplant, including but not limited to antiviral or immunomodulatory product, any interferon product, or RBV, either as monotherapy or in combination.
  • Subjects with other organ transplants.
  • Any subject who received a positive hepatitis C core antibody (HBcAb) or HCV positive donor liver graft.
  • Retransplantation of the liver for rejection or graft failure.
  • Evidence of decompensated liver disease.
  • Known coagulopathies including hemophilia.
  • Known hemoglobinopathies.
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Hypersensitivity to alpha interferon and/or RBV.
  • Co-infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
  • Evidence of active or suspected malignancy or a history of malignancy within the last 5 years (with the exception of pre-transplant hepatocellular carcinoma histologically within the Milan criteria, and adequately treated basal or squamous cell carcinoma of the skin).
  • Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
  • Subject is or was a substance abuser. Subjects treated with buprenorphine (Subutex) who have been stable for 6 months may be included.
  • Patients weighing over 135 kg;

Is participating in any other clinical study(ies);

Is allergic to or has sensitivity to the study drug or its excipients.

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00378599     History of Changes
Other Study ID Numbers: P04590
First Posted: September 20, 2006    Key Record Dates
Results First Posted: July 16, 2010
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Interferon alpha-2
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Disease Attributes
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs