Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

NCT02247401 | Completed Phase 3 Results

• 1 other identifier: M14-250
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

Conditions

HCV; Hepatitis C Infection; Genotype 4

Keywords

Genotype 4; non-responder; treatment experienced; HCV; naive; relapser; hepatitis infection; compensated cirrhosis; hepatitis c; Cirrhosis; Egypt; null responder; partial responder

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm

  SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study drug.

  12 weeks after last dose

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

  Screening until 30 days after last dose

Secondary Outcomes (2)

• Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm

  Up to 12 or 24 weeks after first dose

• Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm

  Up to 12 weeks after first dose

Study Arms (3)

Arm A

ACTIVE COMPARATOR

ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent \[DAA\]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.

Drug: 2 DAA; Drug: RBV

Arm B

ACTIVE COMPARATOR

ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.

Drug: 2 DAA; Drug: RBV

Arm C

ACTIVE COMPARATOR

ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.

Drug: 2 DAA; Drug: RBV

Interventions

2 DAA DRUG

ABT-450/r/ABT-267 tablets

Arm A; Arm B; Arm C

RBV DRUG

Ribavirin tablets

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C, genotype 4-infection (hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] level greater than 1,000 IU/mL at Screening)
• Subjects must meet one of the following:
• Treatment-naive: Subject has never received antiviral treatment for HCV infection OR
• Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon \[pegIFN\]/RBV);
• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
• In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
• In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

You may not qualify if:

• Females who are pregnant or breastfeeding
• Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
• HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
• abnormal laboratory tests
• self-reports current drinking more than 2 drinks per day
• current enrollment in another investigational study
• previous treatment with a direct acting antiviral agent (DAA) containing regimen
• In substudy 1, evidence of liver cirrhosis
• In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Waked I, Shiha G, Qaqish RB, Esmat G, Yosry A, Hassany M, Soliman R, Mohey MA, Allam N, Zayed N, Asselah T, Hall C, Redman R, Mobashery N, Doss W. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):36-44. doi: 10.1016/S2468-1253(16)30002-4. Epub 2016 Jun 16.

  PMID: 28404110 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Fibrosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Sarah Kopecky-Bromberg, PhD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 25, 2014
• Study Start: November 4, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 30, 2021
• Results First Posted: July 27, 2017

Record last verified: 2021-07