E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019752 |
E.1.2 | Term | Hepatitis C virus (HCV) |
E.1.2 | System Organ Class | 100000004848 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To:
- Assess the durability of response for subjects who achieved SVR12 with a regimen including
ABT-493 and/or ABT-530.
- Assess the emergence and persistence of specific HCV amino acid variants associated with drug resistance in subjects who experience virologic failure. |
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E.2.2 | Secondary objectives of the trial |
To:
(1) Summarize medical events related to progression of liver disease including: events of hepatic decompensation, change in Child-Pugh classification, liver transplantation, hepatocellular carcinoma, death.
(2) Summarize results of the following laboratory tests and scores: Fibro Test, APRI, IP-10, alpha fetoprotein, FibroScan and liver biopsy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject has received at least 1 dose of an ABT-493 and/or ABT-530 containing regimen in a prior AbbVie HCV Phase 2 or 3 study which has been conducted under US IND.
2. Interval between last dose of AbbVie ADD therapy from the previous study and enrollment in M13-576 must be no longer than 2 years.
3. The subject must voluntarily sign/date the informed consent form approved by an IRB/EC prior to the initiation of any study-specific procedures.
4. Subject completed the post-treatment period of an eligible prior study. |
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E.4 | Principal exclusion criteria |
1. Investigator considers the subject unsuitable for the study for any reasons.
2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study.
3. Subject who experienced non-virologic treatment failure due to premature discontinuation of study drug in the prior study of ABT-493 and/or ABT-530.
4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failures in the prior Phase 2 or 3 study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of subjects who maintain a sustained virologic response; Assessing persistence of resistance-associated amino acid variants |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1, Month 3, Month 6 and every 6 months thereafter. |
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E.5.2 | Secondary end point(s) |
Number of medical events related to progression of liver disease; Participant Fibro Test score; Participant aspartate transaminase to platelet ratio index (APRI) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1, Month 3, Month 6 and every 6 months thereafter. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Long Term Follow Up Study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Puerto Rico |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |