A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients

NCT01782495 | Completed Phase 2 Results DMC

• 2 other identifiers: M12-9992012-004792-39
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection.

Conditions

Chronic Hepatitis C Infection

Keywords

Hepatitis C Genotype 4; Chronic Hepatitis; Interferon-Free; Hepatitis C Virus (HCV); Renal Transplant; Liver Transplant; Hepatitis C Genotype 1

Outcome Measures

Primary Outcomes (1)

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

  SVR12 was defined as plasma 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. Participants with missing data after backward imputation were imputed as nonresponders.

  12 weeks after the last actual dose of study drug

Secondary Outcomes (3)

• Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

  24 weeks after the last actual dose of study drug

• Percentage of Participants With On-treatment Virologic Failure

  Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)

• Percentage of Participants With Post-treatment Relapse

  From the end of treatment through 12 weeks after the last dose of study drug

Study Arms (11)

Arm A

EXPERIMENTAL

Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin

Arm B

EXPERIMENTAL

Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin

Arm C

EXPERIMENTAL

Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Arm D

EXPERIMENTAL

Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin

Arm E

EXPERIMENTAL

Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin

Arm F

EXPERIMENTAL

Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin

Arm G

EXPERIMENTAL

Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Arm H

EXPERIMENTAL

Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin

Arm I

EXPERIMENTAL

Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Arm J

EXPERIMENTAL

Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir; Drug: ribavirin

Arm K

EXPERIMENTAL

Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Drug: ombitasvir/paritaprevir/ritonavir; Drug: ribavirin

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvir DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Also known as: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F; Arm G; Arm H; Arm I

ombitasvir/paritaprevir/ritonavir DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Also known as: TECHNIVIE, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267

Arm J; Arm K

ribavirin DRUG

tablet

Arm A; Arm B; Arm D; Arm E; Arm F; Arm H; Arm J; Arm K

Eligibility Criteria

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

You may qualify if:

• Male or female, at least 18 years of age at the time of screening.
• Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine. Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 10 mg/day.
• Hepatitis C virus (HCV) interferon (IFN) therapy treatment-naïve or -experienced, either pre- or post-liver or renal transplant.
• Screening HCV genotype testing indicating infection with genotype 1 or 4 (GT1 or GT4) only.

You may not qualify if:

• Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
• Use of any medications contraindicated for use with the study regimen as well as those that are contraindicated for use with either ritonavir or ribavirin within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer.
• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
• Documented history of post-transplant complications directly involving the hepatic or renal vasculature as appropriate to the organ transplanted, e.g., thrombosis of the portal vein, the hepatic artery and/or hepatic vein.
• Clinically significant abnormalities, other than HCV infection, in a subject post-transplant based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown R Jr, Gordon F, Levitsky J, Terrault NA, Burton JR Jr, Xie W, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Forns X. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med. 2014 Dec 18;371(25):2375-82. doi: 10.1056/NEJMoa1408921. Epub 2014 Nov 11.

  PMID: 25386767 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis, Chronic; Hepatitis C

Interventions

ombitasvir; dasabuvir; Viekira Pak; paritaprevir; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• AbbVie Inc

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: February 4, 2013
• Study Start: February 25, 2013
• Primary Completion: November 2, 2016
• Study Completion: July 13, 2017
• Last Updated: November 7, 2017
• Results First Posted: November 7, 2017

Record last verified: 2017-10