The Effects of PegIntron Plus Rebetol in Subjects With Chronic Hepatitis C Not Responding to Pegasys (Study P03833)

NCT00441584 | Terminated Phase 3 Results

• 2 other identifiers: P03833ESPECIAL
• Study Type: interventional
• Target: 117
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve sustained virological response (SVR) when treated with PegIntron plus Rebetol.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment

  Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is \< 30 IU/mL in this study.

  Up to 48 weeks of treatment plus 24 weeks follow up

Study Arms (1)

PegIntron plus Rebetol

EXPERIMENTAL

PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks

Biological: PegIntron (peginterferon alfa-2b); Drug: Rebetol (ribavirin)

Interventions

PegIntron (peginterferon alfa-2b) BIOLOGICAL

Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks

Also known as: SCH 54031, PEG-Intron, PegIntron, ViraferonPeg, peginterferon alfa-2b

PegIntron plus Rebetol

Rebetol (ribavirin) DRUG

200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks

Also known as: SCH 18908, Rebetol, REBETOL, ribavirin

PegIntron plus Rebetol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Subject must be 18-70 years of age of either sex and of any race.
• Subject must be diagnosed with chronic hepatitis C genotype 1 (confirmation by biopsy not required). (Liver function tests (LFTs) can be normal or elevated.)
• Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control. While abstinence from sexual activity is the only certain method to prevent pregnancy, female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use a combination of the following 2 methods:
• Contraceptive pill or intrauterine device (IUD) or depot hormonal preparation (ring, injection, implant), and
• A barrier method of contraception such as diaphragm, sponge with spermicide, condom, or a method of birth control considered acceptable by the study physician.
• Contraceptive measures will be reviewed with female subjects at each visit. Dual methods of contraception must be used for 6 months after treatment discontinuation.
• Female subjects of childbearing potential must have a negative serum pregnancy test at screen phase and during the study.
• Confirmation by the principal investigator or a sub-investigator that sexually active male subjects are practicing a method of contraception considered acceptable (vasectomy, condom plus spermicide, plus relationship with a female partner who practices an acceptable method of contraception). Contraception must be used during the treatment period and for seven months after the completion of therapy, including condom use by male subjects with pregnant partners.
• Subject must be free of any clinically significant disease that would interfere with study evaluations.
• Subject must understand, be able to and agree to adhere to the dosing and visit schedules.
• Compensated liver disease with the following minimum hematologic and biochemical criteria at the Day 1 visit within normal limits:
• Hemoglobin values equal to or greater than 12 g/dL for females and 13 g/dL for males
• White blood cell (WBC) count equal to or greater than 3,000/cu mm
• Neutrophil count equal to or greater than 1,500/cu mm

You may not qualify if:

• Subject is a female who is pregnant or breastfeeding, or who intends to become pregnant during the study.
• Subject has used any investigational product within 30 days prior to enrollment or is currently involved in another clinical trial.
• Subjects weighing over 125 kg.
• Subject has any of the following causes for the liver disease based on subject history or biopsy (where applicable) other than chronic hepatitis C, including but not limited to:
• Hemochromatosis
• Alpha-1 antitrypsin deficiency
• Wilson's disease
• Autoimmune hepatitis
• Alcoholic liver disease
• Non-alcoholic steatohepatitis (NASH)
• Drug-related liver disease
• Subject has any clinically significant deviation from normal in the physical examination, chest x-ray, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety.
• Subject is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
• Subject is part of the staff or a family member of the staff personnel directly involved with this study.
• Subject is a previously untreated subject.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Integrated Therapeutics Group: collaborator

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; 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

Limitations and Caveats

Due to slow enrollment, an unplanned interim analysis was conducted: 75 of 93 (80.6%) subjects who had reached treatment Week 12 did not achieve early virologic response. Given the low likelihood of response, a decision was made to stop enrollment.

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
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: July 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 5, 2017
• Results First Posted: August 4, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share