Clinical Trials List
Protocol NumberM13-596
NCT Number(ClinicalTrials.gov Identfier)NCT02692703
2016-03-14 - 2017-09-07
Phase III
Terminated2
ICD-10B18.2
Chronic viral hepatitis C
ICD-10B18
Chronic viral hepatitis
ICD-9070.54
Chronic hepatitis C without mention of hepatic coma
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 Subjects with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (MAGELLAN-2)
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Che-Chuan Loong Division of Others -
- 夏振源 Division of General Surgery
The Actual Total Number of Participants Enrolled
4 Terminated
Audit
None
Co-Principal Investigator
- 何承懋 Division of General Surgery
- REY-HENG HU Division of General Surgery
- Ming-Chih Ho Division of General Surgery
- Yao-Ming Wu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Post-Liver or Post-Renal Transplant Subjects with Chronic Hepatitis C Virus Genotype 1 – 6 Infection
Objectives
The primary objectives of this study are to assess the efficacy (12-week sustained virologic
response, SVR12 [HCV RNA < LLOQ 12 weeks following therapy]) of 12 weeks of treatment with the
ABT-493/ABT-530 combination regimen in adults with HCV genotype GT1 – 6 infection who are
DAA-naïve and post primary orthotopic liver transplant or renal transplant and to assess the safety of
treatment with the ABT-493/ABT-530 combination regimen for 12 weeks in adults with HCV
genotype GT1 – 6 infection and post primary orthotopic liver transplant or renal transplant.
Test Drug
ABT-493/ABT-530
Active Ingredient
ABT-493/ABT-530
Dosage Form
tablet
Dosage
100/40
Endpoints
Primary Outcome Measures :
1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last dose of study drug (up to 24 weeks) ]
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Secondary Outcome Measures :
1. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 12 weeks ]
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
2. Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks) ]
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 < LLOQ at the end of treatment.
1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last dose of study drug (up to 24 weeks) ]
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Secondary Outcome Measures :
1. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 12 weeks ]
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
2. Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks) ]
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 < LLOQ at the end of treatment.
Inclution Criteria
Main Inclusion:
1 Male or female, at least 18 years of age at time of screening.
2. Screening laboratory result indicating HCV GT1 – 6 infection.
3. Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of
HCV infection ≥ 3 months prior to screening Or Subject received a cadaveric or living donor kidney
at least ≥ 3 months before screening.
4. Subjects must be documented as non-cirrhotic.
5. Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus,
everolimus, mycophenolate mofetil, azathioprine, or cyclosporine.
1 Male or female, at least 18 years of age at time of screening.
2. Screening laboratory result indicating HCV GT1 – 6 infection.
3. Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of
HCV infection ≥ 3 months prior to screening Or Subject received a cadaveric or living donor kidney
at least ≥ 3 months before screening.
4. Subjects must be documented as non-cirrhotic.
5. Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus,
everolimus, mycophenolate mofetil, azathioprine, or cyclosporine.
Exclusion Criteria
Main Exclusion:
1. 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.
2. Clinical history of fibrosing cholestatic hepatitis post-transplant.
3. Re-transplantation of the liver or kidney.
4. Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with
high dose steroid within 3 months of screening.
5. History of post-transplant complications related to hepatic or renal vasculature.
1. 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.
2. Clinical history of fibrosing cholestatic hepatitis post-transplant.
3. Re-transplantation of the liver or kidney.
4. Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with
high dose steroid within 3 months of screening.
5. History of post-transplant complications related to hepatic or renal vasculature.
The Estimated Number of Participants
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Taiwan
14 participants
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Global
90 participants
