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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study (MAGELLAN-3)

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ClinicalTrials.gov Identifier: NCT02939989
Recruitment Status : Enrolling by invitation
First Posted : October 20, 2016
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of co-administration of ABT-493/ABT-530 plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic participants) who have experienced virologic failure in an AbbVie parent clinical study.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: Sofosbuvir Drug: ABT-493/ABT-530 Drug: Ribavirin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)
Actual Study Start Date : November 21, 2016
Estimated Primary Completion Date : October 21, 2022
Estimated Study Completion Date : March 24, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABT-493/ABT-530 + SOF + RBV for 16 weeks
ABT-493/ABT-530 (300/120 mg) QD + SOF (400 mg) QD + RBV (600 - 1200 mg) daily in two divided doses (based on baseline age and weight) for 16 weeks.
Drug: Sofosbuvir
Tablet
Other Name: SOVALDI

Drug: ABT-493/ABT-530
Tablet

Drug: Ribavirin
Tablet

Experimental: ABT-493/ABT-530 + SOF + RBV for 12 weeks
ABT-493/ABT-530 (300/120 mg) QD + SOF (400 mg) QD + RBV (600 - 1200 mg) daily in two divided doses (based on baseline age and weight) for 12 weeks.
Drug: Sofosbuvir
Tablet
Other Name: SOVALDI

Drug: ABT-493/ABT-530
Tablet

Drug: Ribavirin
Tablet




Primary Outcome Measures :
  1. Percentage of participants with sustained virologic response 12 weeks post dosing (SVR12) [ Time Frame: 12 weeks after last dose of study drug ]
    Percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (LLOQ) (less than 15 IU/mL) 12 weeks after the last actual dose of study drug.


Secondary Outcome Measures :
  1. Percentage of participants with on-treatment virologic failure. [ Time Frame: Treatment Day 1 to end of treatment (up to 12 or 16 weeks depending on treatment arm) ]
    On treatment virologic failure is defined as confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurement of > 1 log10 IU/mL above nadir) at any time point during treatment; or confirmed HCV RNA ≥ 100 IU/mL (defined as 2 consecutive HCV RNA measurements ≥ 100 IU/mL) after HCV RNA < LLOQ during treatment.

  2. Percentage of participants with post-treatment HCV virologic relapse [ Time Frame: Up to 24 weeks after last dose of study drug ]
    Percentage of participants with confirmed quantifiable HCV RNA after completion of treatment among participants with unquantifiable HCV RNA at the end of treatment.



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Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects must be adults (18 years of age or older) or adolescents (12 to less than 18 years of age weighing at least 35 kg).
  • Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at AbbVie's discretion. Treatment in the parent study must have been completed or discontinued at least 1 month prior to the Screening Visit.
  • Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
  • Cirrhotic Subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at Screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
  • Cirrhotic Subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.

Exclusion Criteria:

  • History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
  • Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label, whichever is more restrictive.
  • 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, and failure in an AbbVie HCV parent study due to non-virologic reasons.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg).
  • Screening laboratory analyses showing calculated creatinine clearance < 30 mL/min.
  • Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
  • Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939989


  Show 20 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02939989     History of Changes
Other Study ID Numbers: M15-942
2016-002491-26 ( EudraCT Number )
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Chronic Hepatitis C (HCV)
HCV Genotype 1 (HCV GT1)
HCV Genotype 2 (HCV GT2)
HCV Genotype 3 (HCV GT3)
HCV Genotype 4 (HCV GT4)
HCV Genotype 5 (HCV GT5)
HCV Genotype 6 (HCV GT6)
Compensated Cirrhosis
Non-cirrhotics
Virologic failure
Hepatitis C Virus Infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents