Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)

Hepatitis C Clinical Trial

Official title:

PREDICT - Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negative HCV-RNA At Week 4 and at Week 24

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709228
• Other study ID #: P04793
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: January 14, 2015
• Start date: May 2006
• Est. completion date: November 2008

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.

Description:

Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willingness to participate

• 18 years or older, either gender, any race

• Must have Hepatitic C Virus Low Viral Load [LCV LVL] (positive, but <600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction [HCV-RNA/qPCR] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1

• Subject considered suitable for treatment per local label

• Investigator considers suitable and subject consents to be treated

Exclusion Criteria:

• Does not show negative polymerase chain reaction [PCR] at week 4

• Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant

• Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the Summary of Product Characteristics [SmPC]

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• PegIntron
1.5 ug/kg/week
• Rebetol
800-1200 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Craxi A, Koutsounas S, Ogurtsov P, Chemello L, Maticic M, Torras J, Diago M, Tartaglione MT, Witthoeft T, Yu X, Faruqi R, Chaudhri E, Pedicone LD, Zuckerman E. Peginterferon alfa-2b plus weight-based ribavirin for 24 weeks in patients with chronic hepatit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HCV LVL G1 Participants Who Relapsed	Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.	Week 24 of follow-up	No