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A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02692703
First received: February 23, 2016
Last updated: April 6, 2017
Last verified: April 2017
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Purpose
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 in adults who are post primary orthotopic liver or renal transplant with chronic Hepatitis C Virus infection.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Hepatitis C HCV Hepatitis C Virus | Drug: ABT-493/ABT-530 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | A Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (MAGELLAN-2) |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Percentage of Participants with Sustained Virologic Response 12 weeks After Treatment compared to the historical Sustained Virologic Response 12 weeks. [ Time Frame: 12 weeks after the last dose of study drug ]Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug.
Secondary Outcome Measures:
- The percentage of participants with on-treatment virologic failure [ Time Frame: Up to Week 12 ]The percentage of participants with confirmed increase of > 1 log10 IU/mL in HCV RNA above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment)
- The percentage of participants with post-treatment relapse [ Time Frame: Up to 12 weeks after the last dose of study drug ]Percentage of participants with confirmed quantifiable HCV RNA between end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with unquantifiable HCV RNA at the end of treatment.
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2016 |
| Estimated Study Completion Date: | June 2017 |
| Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ABT-493/ABT-530
ABT-493/ABT-530 for 12 weeks
|
Drug: ABT-493/ABT-530
Tablet
|
Eligibility| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, at least 18 years of age at time of screening.
- Screening laboratory result indicating HCV GT1 - 6 infection.
- Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or Subject received a cadaveric or living donor kidney at least 3 months before screening.
- Subjects must be documented as non-cirrhotic.
- Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine.
Exclusion Criteria:
- Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
- Clinical history of fibrosing cholestatic hepatitis post-transplant.
- Re-transplantation of the liver or kidney.
- Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening.
- History of post-transplant complications related to hepatic or renal vasculature.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02692703
Show 27 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02692703
Show 27 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | Susan Rhee, MD | AbbVie |
More Information
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT02692703 History of Changes |
| Other Study ID Numbers: |
M13-596 2015-005616-14 ( EudraCT Number ) |
| Study First Received: | February 23, 2016 |
| Last Updated: | April 6, 2017 |
Keywords provided by AbbVie:
|
HCV Treatment Experienced Hepatitis C HCV Genotype 3 Without cirrhosis Non-cirrhotic HCV Genotype 2 Renal Transplant HCV Treatment Naive |
Post transplant HCV Genotype 6 Liver Transplant HCV Genotype 5 HCV Genotype 4 Kidney Transplant HCV Genotype 1 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 26, 2017