A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection

Chronic Hepatitis C Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604017
• Other study ID #: M13-590
• Secondary ID: 2015-002087-17
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: January 2017

Study information

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

Clinical Trial Summary

This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, at least 18 years of age at time of screening.

• Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.

• Chronic HCV infection.

• Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).

• Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

• HIV-1 antiretroviral treatment (ART) naïve with CD4 = 500 cells/mm3 (or CD4+ % = 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.

OR

• On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 = 200 cells/mm3 (or CD4+ % =14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.

• Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.

• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.

• Positive test result at Screening for hepatitis B surface antigen (HBsAg).

• HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

• Chronic HIV type 2 (HIV-2) infection.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• HCV
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, Asselah T, Bourlière M, Ruane PJ, Wedemeyer H, Pol S, Flisiak R, Poordad F, Chuang WL, Stedman CA, Flamm S, Kwo P, Dore GJ, Sepulveda-Arzola G, Roberts SK, Soto-Malave R, Kaita K, Puoti M, Vierling J, Tam E, Vargas HE, Bruck R, Fuster F, Paik SW, Felizarta F, Kort J, Fu B, Liu R, Ng TI, Pilot-Matias T, Lin CW, Trinh R, Mensa FJ. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018 Jan 25;378(4):354-369. doi: 10.1056/NEJMoa1702417. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [	12 weeks after the last actual dose of study drug
Primary	Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later	SVR12 was defined as plasma HCV RNA level	12 weeks after last actual dose of study drug
Primary	Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants	SVR12 was defined as plasma HCV RNA level	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants	SVR12 was defined as plasma HCV RNA level	12 weeks after last actual dose of study drug
Secondary	Percentage of Participants With SVR12	SVR12 was defined as plasma HCV RNA level	12 weeks after last actual dose of study drug
Secondary	Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants	SVR12 was defined as plasma HCV RNA level	12 weeks after last actual dose of study drug
Secondary	Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants	SVR12 was defined as plasma HCV RNA level	12 weeks after last actual dose of study drug
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA =100 IU/mL after HCV RNA	Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
Secondary	Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants	On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA =100 IU/mL after HCV RNA	Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
Secondary	Percentage of Participants With Post-treatment Relapse	Post-treatment relapse was defined as confirmed HCV RNA =LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels	From the end of treatment through 12 weeks after the last dose of study drug
Secondary	Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants	Post-treatment relapse was defined as confirmed HCV RNA =LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels	From the end of treatment through 12 weeks after the last dose of study drug

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