A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

Chronic Hepatitis C Infection Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715415
• Other study ID #: M13-098
• Secondary ID: 2012-002035-29
• Status: Completed
• Phase: Phase 3
• Start date: November 2012
• Est. completion date: October 2014

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: October 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.

• Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.

• Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).

• No evidence of liver cirrhosis.

Exclusion Criteria:

• Positive screen for drugs or alcohol.

• Significant sensitivity to any drug.

• Use of contraindicated medications within 2 weeks of dosing.

• Certain predefined abnormal laboratory tests.

• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
• Ribavirin
Capsule (double-blind treatment period), tablet (open-label treatment period)
• Placebo for ABT-450/r/ABT-267
Tablet
• Placebo for ABT-333
Tablet
• Placebo for ribavirin
Capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

References & Publications (1)

Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourlière M, Sulkowski MS, Wedemeyer H, Tam E, Desmond P, Jensen DM, Di Bisceglie AM, Varunok P, Hassanein T, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Retreat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment	The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.	12 weeks after the last actual dose of active study drug
Secondary	Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period	Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.	At 12 weeks
Secondary	Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment	The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.	12 weeks after the last actual dose of active study drug
Secondary	Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment	The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.	12 weeks after the last actual dose of active study drug
Secondary	Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm	Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] = lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA = LLOQ with at least 36 days of treatment) during treatment.	12 weeks after the last actual dose of active study drug
Secondary	Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm	Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (= LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.	Within 12 weeks post-treatment

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