A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study

Browse trials for

• Hepatitis C 2,356
• Hepatitis C, Chronic 1,090

Keywords

• Chronic Hepatitis C
• Hepatitis C virus
• Direct Acting Antiviral
• Sustained Virologic Response
• Hepatitis C
• Persistence of treatment-emergent substitutions

Hepatitis C

2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.

This study's enrollment of 478 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.

Lead sponsor

AbbVie (prior sponsor, Abbott) is the lead sponsor of 223 studies on the registry; none are open to participants now.

Study arms

• Other
  All Participants

  Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.

  Drug: ABT-450/ritonavir · Drug: ABT-333 · Drug: ABT-267

Interventions

• DrugABT-450/ritonavir

  Drug pages: Paritaprevir · Ritonavir

  ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.

  Also known as: ABT-450 also known as paritaprevir

• DrugABT-333

  Drug is not administered -- this study is follow-up for participants previously receiving the drug.

  Also known as: dasabuvir

• DrugABT-267

  Drug is not administered -- this study is follow-up for participants previously receiving the drug.

  Also known as: ombitasvir

Primary outcomes

1. Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection

   Relapse is defined as a confirmed HCV ribonucleic acid (RNA) ≥ the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA \< LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.

   Time frame: Up to 3 years post-treatment

2. Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B

   The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.

   Time frame: from the last dose of study drug in the previous study up to 3 years post-treatment

Secondary outcomes

1. Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection

   Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.

   Time frame: From the end of treatment through 12 weeks post-treatment

2. Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection

   Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.

   Time frame: From the end of treatment through 24 weeks post-treatment

3. Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection

   Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.

   Time frame: Up to 3 years post-treatment

Baseline characteristics