Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)

NCT00302081 | Completed Phase 3 Results

• 1 other identifier: P03548
• Study Type: interventional
• Target: 696
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\] .

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic; Genotype 2 and Genotype 3

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Achieve a Sustained Virologic Response (SVR)

  A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid \[HCV-RNA\] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.

  24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.

Secondary Outcomes (1)

• Virologic Response Rates at the End of Therapy. Biochemical Responses as Determined by ALT and AST Levels at the End of Treatment and at the End of Follow up.

  End of treatment: 24 weeks for arms [PEG2b 1.5/R (24 weeks)] and [PEG2b 1.0/R (24 weeks)]; 16 weeks for arm [PEG2b 1.5/R (16 weeks)]. Follow-up of 24 weeks for each arm.

Study Arms (3)

PEG2b 1.5/R (24 weeks)

ACTIVE COMPARATOR

PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks

Biological: peginterferon alfa-2b (SCH 54031); Drug: ribavirin (SCH 18908)

PEG 2b 1.0/R (24 weeks)

EXPERIMENTAL

PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks

Biological: peginterferon alfa-2b (SCH 54031); Drug: ribavirin (SCH 18908)

PEG2b 1.5/R (16 weeks)

EXPERIMENTAL

PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks

Biological: peginterferon alfa-2b (SCH 54031); Drug: ribavirin (SCH 18908)

Interventions

peginterferon alfa-2b (SCH 54031) BIOLOGICAL

1.5 mcg/kg QW SC for 24 weeks

Also known as: PegIntron (SCH 54031)

PEG2b 1.5/R (24 weeks)

ribavirin (SCH 18908) DRUG

800-1200 mg daily for 24 weeks

Also known as: REBETOL (SCH 18908)

PEG 2b 1.0/R (24 weeks); PEG2b 1.5/R (24 weeks)

Eligibility Criteria

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

You may qualify if:

• The subject must meet ALL of the criteria listed below for entry into the study:
• Hemoglobin \>= 11 g/dL (females); \>= 12 g/dL (males)
• Platelet count \>= 100,000/mm\^3
• Neutrophil count \>= 1,500/mm\^3
• Adult male or female chronic hepatitis C (CHC) patients (HCV-RNA-positive in serum) with compensated liver disease (Child-Pugh Score \<7) and indication for treatment according on current consensus guidelines (1. NIH Consensus Conference on the Management of Hepatitis C, 2002; 2. German Consensus Conference on Hepatitis B and C, published in Z Gastro 2004; 42 (8): 677-730).
• \>= 18 to =\< 70 years of age
• At least one abnormal ALT value in the last year
• HCV genotype 2 or 3
• Not previously treated with any interferon or ribavirin alone or in combination
• TSH level must be within normal limits
• At the Screen Visit, glucose must be 70-140 mg/dL. Results between 116-140 mg/dL require repeat fasting glucose to be less than140 mg/dL and HbA1C less than or equal to 8.5%. HbA1C must be less than or equal to 8.5% in diabetic subjects (whether on medication or diet controlled).
• 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: (1)contraceptive pill or IUD or depot hormonal preparation (ring, injection implant); and (2) 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.
• Sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom plus spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment
• Subjects must be willing to give written informed consent and able to adhere to dosing and visit schedules.
• Confirmation by the principal investigator or a sub-investigator that sexually active females of childbearing potential are practicing adequate contraception.

You may not qualify if:

• Patients younger than 18 years
• Patients older than 70 years of age.
• Positive Anti-HIV antibodies
• Positive HBsAg antibodies
• Patients with severe renal dysfunction or creatinine clearance \< 50 mL/min must not be treated with PEG-Intron -Rebetol
• Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women.
• Suspected hypersensitivity to any interferon or ribavirin product.
• Subject has used any investigational product within 30 days prior to enrollment
• Subject is participating in any other clinical study
• Any cause of liver disease other than chronic hepatitis C, including but not limited to:
• Hemochromatosis
• Alpha-1 antitrypsin deficiency
• Wilson's disease
• Autoimmune hepatitis
• Alcoholic liver disease

Sponsors & Collaborators

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

Related Publications (1)

• Manns M, Zeuzem S, Sood A, Lurie Y, Cornberg M, Klinker H, Buggisch P, Rossle M, Hinrichsen H, Merican I, Ilan Y, Mauss S, Abu-Mouch S, Horban A, Muller TH, Welsch C, Chen R, Faruqi R, Pedicone LD, Wedemeyer H. Reduced dose and duration of peginterferon alfa-2b and weight-based ribavirin in patients with genotype 2 and 3 chronic hepatitis C. J Hepatol. 2011 Sep;55(3):554-563. doi: 10.1016/j.jhep.2010.12.024. Epub 2011 Jan 13.

  PMID: 21237227 DERIVED

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

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 13, 2006
• Study Start: August 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 5, 2017
• Results First Posted: August 11, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share