Clinical Trials Logo

Clinical Trial Summary

The purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus (HCV)-infected participants.


Clinical Trial Description

This was a Phase 2a, blinded, randomized, placebo-controlled clinical trial in hepatitis C virus (HCV)-infected adults with 2 planned sequential evaluations, Part 1 and Part 2. The study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-333 or placebo monotherapy, followed by 26 days of ABT-333 or placebo with pegylated interferon a-2a (pegIFN) and ribavirin (RBV) combination therapy. Review of safety and efficacy in Part 1 of the study showed similar response rates across ABT-333 doses so Part 2 of the study was not performed. The study also assessed emergence of resistant HCV in conjunction with kinetics of viral load decay and rebound in treatment-naïve, HCV-infected participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00851890
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 2
Start date March 2009
Completion date July 2009

See also
  Status Clinical Trial Phase
Completed NCT01708889 - Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction Phase 1
Active, not recruiting NCT00563173 - Phase I/IIa Dose Ranging CHRONVAC-C® Study in Chronic HCV Patients Phase 1/Phase 2
Withdrawn NCT01813266 - Prospective Cohort Study: To Provide Evidence & Guidance in Hepatitis C Virus Screening, Comparing the New Birth Cohort Recommendations From the CDC, Versus Classical Traditional Strategies With Established Risk Factors
Completed NCT01121731 - A Phase I/II Clinical Trial With Interferon Alfa 5 in Treatment-Experienced Patients With Genotype-1 Chronic Hepatitis C Phase 1/Phase 2
Completed NCT04391985 - Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients Phase 1/Phase 2
Completed NCT04387539 - ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants Phase 1/Phase 2
Completed NCT00770198 - sgp130 in Chronic Human Liver Disease N/A
Completed NCT04382937 - Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection Phase 3
Completed NCT00606528 - FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy N/A
Recruiting NCT00294489 - Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT Phase 3
Withdrawn NCT00255359 - Safety, Tolerability and Efficacy of XTL 2125 in HCV-Infected Patients Who Are Interferon-Alpha Non-Responders or Relapsers Phase 1
Completed NCT00570336 - Study of CTS-1027 in Hepatitis C Patients Phase 2
Completed NCT02292719 - A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection Phase 2
Terminated NCT01080222 - A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection Phase 2
Completed NCT04385407 - Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients Phase 2
Completed NCT04387526 - Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4 Phase 2/Phase 3
Completed NCT00215865 - PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy Phase 3