TOPAZ-I

A Study to Evaluate Long-term Outcomes Following Treatment With a combination of 2 Active Drugs With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Brief summary

The purpose of this study is to evaluate Long-term outcomes following treatment with a combination of 2 active drugs with or without RBV in adults with genotype 1 Chronic Hepatitis C Virus (HCV) infection.

Interventional study

Status:
Completed
Conditions:
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Enrollment:
1596 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-423
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 99 Years.

Inclusion Criteria:

1. Males and females at least 18 years old at screening

2. Females must be post-menopausal for more than 2 years or surgically sterile or
practicing acceptable forms of birth control

3. Chronic hepatitis C, genotype 1 infection

4. Males must be surgically sterile or agree to practice acceptable forms of birth
control

5. Screening laboratory result indicating HCV genotype 1 infection

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing

2. Abnormal laboratory tests

3. Current or past clinical evidence of Child-Pugh B or C classification or history of
liver decompensation

4. Confirmed presence of hepatocellular carcinoma

5. History of solid organ transplant

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T5H 4B9
Vancouver - V5Z 1H2
Vancouver - V6Z 2C7
Vancouver - V6Z 2K5
Ottawa - K1H 8L6
Toronto - M5G 2C4
Toronto - M6H 3M1
Vaughan - L4L 4Y7
Montreal - H2L 4P9
Montreal - H3G 1A4
Montreal - H3T 1E2
Quebec - G1V 4G2
Saint John - E2L 4L2
Winnipeg - R3E 3P4

British Columbia

Manitoba

New Brunswick

More information about this study

clinicaltrials.gov