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Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

NCT ID: NCT02114177

Last Updated: 2016-04-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

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The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

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Detailed Description

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This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), multicenter study. The study will consist of a screening phase up to 6 weeks, open-label treatment phase of 8 weeks or 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 300 participants will be randomly allocated in a 1:1 ratio to receive 150 mg simeprevir in combination with 400 mg sofosbuvir once daily either for 12 weeks (Arm 1) or 8 weeks (Arm 2). Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum study duration for each participant will be approximately 42 weeks.

Conditions

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Hepatitis C Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 (Simeprevir/Sofosbuvir)

150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.

Group Type EXPERIMENTAL

Simeprevir

Intervention Type DRUG

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.

Sofosbuvir

Intervention Type DRUG

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.

Arm 2 (Simeprevir/Sofosbuvir)

150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks.

Group Type EXPERIMENTAL

Simeprevir

Intervention Type DRUG

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2

Sofosbuvir

Intervention Type DRUG

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.

Interventions

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Simeprevir

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.

Intervention Type DRUG

Simeprevir

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2

Intervention Type DRUG

Sofosbuvir

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.

Intervention Type DRUG

Sofosbuvir

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization
* Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization
* Documentation of the IL28B genotype before randomization
* HCV ribonucleic acid level greater than 10,000 IU/mL at screening
* Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin
* Absence of cirrhosis in participants

Exclusion Criteria

* Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
* Infection/co-infection with HCV non-genotype 1a or 1b
* Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
* Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive)
* Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Infectious Diseases BVBA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Infectious Diseases BVBA Clinical Trial

Role: STUDY_DIRECTOR

Janssen Infectious Diseases BVBA

Locations

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Dothan, Alabama, United States

Site Status

Bakersfield, California, United States

Site Status

Chula Vista, California, United States

Site Status

Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

Englewood, Colorado, United States

Site Status

Bradenton, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Lauderdale Lakes, Florida, United States

Site Status

Maitland, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Wellington, Florida, United States

Site Status

Zephyrhills, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Columbus, Georgia, United States

Site Status

Marietta, Georgia, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Jackson, Mississippi, United States

Site Status

Kansas City, Missouri, United States

Site Status

Hillsborough, New Jersey, United States

Site Status

Vineland, New Jersey, United States

Site Status

Manhasset, New York, United States

Site Status

New York, New York, United States

Site Status

Asheville, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

East Greenwich, Rhode Island, United States

Site Status

Providence, Rhode Island, United States

Site Status

Greer, South Carolina, United States

Site Status

Germantown, Tennessee, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Nashville, Tennessee, United States

Site Status

Arlington, Texas, United States

Site Status

Austin, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Falls Church, Virginia, United States

Site Status

Norfolk, Virginia, United States

Site Status

Vancouver, British Columbia, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Kwo P, Gitlin N, Nahass R, Bernstein D, Etzkorn K, Rojter S, Schiff E, Davis M, Ruane P, Younes Z, Kalmeijer R, Sinha R, Peeters M, Lenz O, Fevery B, De La Rosa G, Scott J, Witek J. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology. 2016 Aug;64(2):370-80. doi: 10.1002/hep.28467. Epub 2016 Mar 22.

Reference Type DERIVED
PMID: 26799692 (View on PubMed)

Other Identifiers

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TMC435HPC3017

Identifier Type: OTHER

Identifier Source: secondary_id

CR103430

Identifier Type: -

Identifier Source: org_study_id

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