A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

• Register: EUCTR
• Last refreshed on: 6 February 2017
• Main ID: EUCTR2015-003370-33-ES
• Date of registration: 15/10/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
• Scientific title: An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
• Date of first enrolment: 27/11/2015
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003370-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, France, Germany, Israel, Italy, Spain, 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. Male or female at least 18 years of age at time of Screening.
2. HCV infection at Screening defined as: Positive for anti-HCV antibody (Ab) at Screening and HCV RNA > 1,000 IU/mL at Screening
3. Screening laboratory result indicating HCV genotype 1b infection only
4. Subject has never received commercial or investigational anti-HCV agents for hepatitis C infection (treatment-naïve subject).
5. Absence of cirrhosis, as documented by meeting one of the following criteria (per local standard practice):
? A liver biopsy within 12 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a METAVIR Score of 3 or less, Ishak score of 4 or less;
? A FibroScan performed within 3 months prior to or during screening with a score of < 12.5 kPa; or
? A screening FibroTest score of ? 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ? 2 (Subjects with a screening FibroTest result that is ? 0.72 and an APRI > 2, or a FibroTest result that is > 0.72 and an APRI ? 2 must have a FibroScan or liver biopsy performed during screening to document absence of cirrhosis. These subjects will be allowed to enroll only with approval of the AbbVie Scientific Director).
If more than one method is used to determine the presence or absence of cirrhosis, the results of a liver biopsy will take precedence over FibroScan and FibroTest and the results of FibroScan will take precedence over FibroTest.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
1. Evidence of HCV genotype or subtype other than GT1b during screening, including the presence of GT1b with another genotype or GT1 subtype.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) (test).
3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices or prior biopsy showing cirrhosis.
4. Screening laboratory analyses showing any of the following abnormal laboratory results:
? Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min
? Albumin < 3.5 g/dL
? Hemoglobin < 10 g/dL
? Platelets < 120,000 cells per mm3
? Total bilirubin ? 3.0 mg/dL
? International normalized ratio (INR) > 1.5. Subjects with a known inherited blood disorder and INR > 1.5 may be enrolled with permission of the AbbVie Scientific Director.
5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the subject an unsuitable candidate for this study or to receive ombitasvir/paritaprevir/ritonavir or dasabuvir in the opinion of the investigator.


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

Health Condition(s) or Problem(s) studied

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

Hepatitis C Infection

Intervention(s)

Trade Name: Ombitasvir/Paritaprevir/Ritonavir 12.5 mg/75 mg/50 mg Film-Coated Tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OMBITASVIR
CAS Number: 1456607-70-7
Current Sponsor code: ABT-267; OMBITASVIR
Other descriptive name: OMBITASVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Current Sponsor code: RITONAVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: PARITAPREVIR
CAS Number: 1456607-71-8
Current Sponsor code: ABT-450; PARITAPREVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Trade Name: Dasabuvir 250 mg Film-Coated Tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DASABUVIR
CAS Number: 1456607-55-8
Current Sponsor code: ABT-333; Dasabuvir
Other descriptive name: ABT-333; Dasabuvir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

Main Objective: ?The primary objective of this study is to assess the efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV ribonucleic acid {RNA} < lower limit of quantification {LLOQ} 12 weeks following treatment]) of coformulated ombitasvir/paritaprevir/ritonavir and dasabuvir for 8 weeks in treatment-naïve adults with HCV genotype 1b infection without cirrhosis.

Timepoint(s) of evaluation of this end point: 12 weeks after the last subject last dose

Secondary Objective: ? Secondary objectives are to assess the percentage of subjects with virologic failure during treatment, the percentage of subjects with virologic relapse post-treatment, and the percentage of female subjects with SVR12 and the percentage of subjects with low baseline viral load (HCV RNA < 6,000,000 IU/mL) with SVR12 in previously untreated adults with genotype 1b HCV infection.

Primary end point(s): The primary efficacy endpoint is number and percentage of ITT subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last dose of study drugs).

Secondary Outcome(s)

Secondary end point(s): 1. The percentage of subjects with on-treatment virologic failure, defined as confirmed HCV RNA ? LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase of at least 1 log10 IU/mL from nadir during treatment, failure to suppress during treatment (all on-treatment values of HCV RNA ? LLOQ) among subjects with at least 6 weeks (active study drug duration ? 36 days) of treatment;
2. The percentage of subjects with post-treatment relapse, defined as confirmed HCV RNA ? LLOQ between end of treatment and 12 weeks after last dose of study drug (up to and including the SVR12 assessment time point) among subjects completing treatment and with HCV RNA < LLOQ at the end of treatment.
3. The percentage of female subjects with SVR12.
4. The percentage of subjects with baseline HCV RNA < 6,000,000 IU/mL with SVR12.

Timepoint(s) of evaluation of this end point: 12 weeks after the last subject last dose

Secondary ID(s)

2015-003370-33-DE

M15-684

Source(s) of Monetary Support

Abbvie Inc.