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Trial record 3 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

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ClinicalTrials.gov Identifier: NCT02613871
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : February 13, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV who are co-infected with HBV in Taiwan.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: LDV/SOF Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
Actual Study Start Date : December 21, 2015
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: LDV/SOF
LDV/SOF FDC for 12 weeks
Drug: LDV/SOF
90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL)) at 12 weeks after stopping study treatment.

  2. Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

  2. Percentage of Participants With HCV RNA < LLOQ While on Treatment [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  3. Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 [ Time Frame: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 ]
  4. HCV RNA Change From Baseline While on Treatment [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 ]
  5. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]

    Virologic failure is defined as :

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or
    • Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)

  6. Plasma HBV DNA Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12 [ Time Frame: Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12 ]
  7. Plasma HBV DNA Change From Baseline at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 [ Time Frame: Baseline; Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 ]
  8. HBsAg Level Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12 [ Time Frame: Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12 ]
  9. HBsAg Level Change From Baseline at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 [ Time Frame: Baseline; Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 ]
  10. Serum Lysyl Oxidase-like 2 (LOXL-2) Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12 [ Time Frame: Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12 ]
  11. Percentage of Participants That Required HBV Therapy During Treatment and up to Posttreatment Week 12 [ Time Frame: Up to Posttreatment Week 12 ]
  12. Percentage of Participants That Required HBV Therapy Up to Posttreatment Week 108 [ Time Frame: Up to Posttreatment Week 108 ]
  13. Fibrosis Status as Assessed by Fibroscan® at Posttreatment Week 12 [ Time Frame: Posttreatment Week 12 ]

    FibroScan® is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan® results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:

    • Presence of cirrhosis = FibroScan® result of > 12.5 kPa
    • Absence of cirrhosis = FibroScan® result of ≤ 12.5 kPa

  14. Fibrosis Status as Assessed by Fibroscan® at Posttreatment Weeks 60 and 108 [ Time Frame: Posttreatment Weeks 60 and 108 ]
  15. Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During Treatment and up to Posttreatment Week 12 [ Time Frame: Up to Posttreatment Week 12 ]
  16. Percentage of Participants That Develop HCC Up to Posttreatment Week 108 [ Time Frame: Up to Posttreatment Week 108 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
  • Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
  • Cirrhosis determination by Fibroscan
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female or male is of childbearing potential

Key Exclusion Criteria:

  • Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • Pregnant or nursing female
  • Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
  • Hepatocellular carcinoma (HCC) or other malignancy
  • Current or prior history of clinical hepatic decompensation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


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): NCT02613871


Locations
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Taiwan
Changhua, Taiwan
Chiayi City, Taiwan
Kaohsiung City, Taiwan
Kaohsiung, Taiwan
Keelung, Taiwan
Taichung, Taiwan
Tainan City, Taiwan
Tainan, Taiwan
Taipei City, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications:
Ledipasvir/sofosbuvir for 12 weeks is safe and effective in patients with chronic hepatitis C and hepatitis B coinfection: A phase 3 study in Taiwan; Journal of Hepatology 2017 vol. 66 | S33-S62, abstract PS-098 [EASL 2017]
Declines in HBsAg Levels Observed during Treatment with Ledipasvir/Sofosbuvir (LDV/SOF) in Patients with Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Infection; Hepatology, Volume 66, Number 1 (Suppl), abstract 1083 [AASLD 2017]

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02613871     History of Changes
Other Study ID Numbers: GS-US-337-1655
First Posted: November 25, 2015    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Coinfection
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Infection
Parasitic Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents