An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

• Register: EUCTR
• Last refreshed on: 22 November 2021
• Main ID: EUCTR2014-001022-14-BG
• Date of registration: 19/01/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
• Scientific title: An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
• Date of first enrolment: 09/03/2015
• Target sample size: 1650
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001022-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Algeria, Australia, Austria, Belgium, Bulgaria, Canada, Denmark, European Union, Finland, France, Germany, Greece, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion criteria

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. Males must be surgically sterile or agree to practice acceptable forms of birth control
4. Chronic HCV infection prior to study enrollment.
5. Screening laboratory result indicating HCV genotype 1 infection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1470
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion criteria:
1. Use of contraindicated medication 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Chronic Hepatitis C Infection
MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Name: ABT-450/r/ABT-267
Product Code: ABT-450/r/ABT-267
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ABT-450
Current Sponsor code: ABT-450
Other descriptive name: A-1043422.0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
INN or Proposed INN: RITONAVIR
Current Sponsor code: RITONAVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: ABT-267
Current Sponsor code: ABT-267
Other descriptive name: A-1233617.0, Ombitasvir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-

Product Name: ABT-333
Product Code: ABT-333
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ABT-333
Current Sponsor code: ABT-333
Other descriptive name: A-998821.5, Dasabuvir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Product Name: Ribavirin
Product Code: Ribavirin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIBAVIRIN
Current Sponsor code: RIBAVIRIN
Other descriptive name: RIBAVIRIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Primary end point(s): The primary endpoint is the incidence of all-cause death, liver-related death, liver decompensation, liver transplantation, hepatocellular carcinoma, and the composite of any of the above outcomes observed during the post-treatment period.

Secondary Objective: To evaluate the long-term progression of fibrosis by baseline fibrosis stage and sustained virologic response, as measured by change from baseline in liver stiffness measured by transient elastography (FibroScan®) when available, in adults with genotype 1 (GT1) chronic HCV infection who received treatment with ABT-450/r/ABT-267 and ABT-333 with or without ribavirin.

To evaluate the percentage of subjects achieving SVR12 with ABT-450/r/ABT-267 and
ABT-333 with or without ribavirin in adults with GT1 chronic HCV infection

Main Objective: The primary objective of this study is to evaluate the effect of response to treatment (assessed by SVR12 status) on the long-term progression of liver disease in adults with chronic HCV GT1 infection who received treatment with ABT-450/r/ABT-267 and ABT-333 with or without ribavirin, as measured by all-cause death, liver-related death, liver decompensation, liver transplantation, and hepatocellular carcinoma.

Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs

Secondary Outcome(s)

Secondary end point(s): 1. The effect of sustained virologic response and baseline fibrosis stage on longitudinal change from baseline in Fibroscan score (assessed at the end of treatment and/or post-treatment visits) will be evaluated by comparing mean change between subjects who achieve SVR12 and those who do not. Point estimates and 95% confidence intervals will be provided.
2. The percentage of subjects achieving SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). The simple percentage of subjects achieving SVR12 will be calculated and a two-sided 95% confidence interval of the percentage will be computed based on Wilson's score method.

Timepoint(s) of evaluation of this end point: 1) 12 weeks after the last dose of study drug.
2) 260 weeks after the last dose of study drug.

Secondary ID(s)

2014-001022-14-PT

M14-423

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 04/02/2015
Contact: