An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection

NCT02278419 | Completed Phase 2

• 2 other identifiers: CR104970TMC435HPC2014
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy of simeprevir in combination with sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in the overall population.

Conditions

Hepatitis C

Keywords

Hepatitis C; Simeprevir; Sofosbuvir; Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12)

  SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]), detectable or undetectable at 12 weeks after EOT.

  12 weeks after end of treatment (EOT) (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)

Secondary Outcomes (6)

• Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4)

  4 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)

• Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24)

  24 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)

• Percentage of Participants With on-treatment Failure

  EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)

• Percentage of Participants With Viral Relapse

  EOT (Week 8 for Group A1, Week 12 for Group A2 and Group B), Weeks 4, 12 and 24 after end of treatment

• Percentage of Participants With On-treatment Response

  Week 1, 2, 4, 8 and EOT for all groups, Week 12 for Group A2 and Group B

Study Arms (3)

Group A1

EXPERIMENTAL

Participants without cirrhosis will receive simeprevir 150 milligram (mg) capsule along with sofosbuvir 400 mg tablet, orally, once daily for 8 weeks.

Drug: Simeprevir; Drug: Sofosbuvir

Group A2

EXPERIMENTAL

Participants without cirrhosis will receive simeprevir 150 mg capsule along with sofosbuvir 400 mg tablet, orally, once daily for 12 weeks.

Drug: Simeprevir; Drug: Sofosbuvir

Group B

EXPERIMENTAL

Participants with cirrhosis will receive simeprevir 150 mg capsule along with sofosbuvir 400 mg tablet, orally, once daily for 12 weeks.

Drug: Simeprevir; Drug: Sofosbuvir

Interventions

Simeprevir DRUG

Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.

Group A1; Group A2; Group B

Sofosbuvir DRUG

Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.

Group A1; Group A2; Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have hepatitis C virus (HCV) genotype 4 infection (confirmed at screening)
• Participant must have HCV ribonucleic acid (RNA) greater than (\>) 10,000 international unit per milliliter (IU/mL) at screening
• In participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography \[CT\] scan, or magnetic resonance imaging \[MRI\]) within 6 months before baseline (Day 1) to exclude hepatocellular carcinoma is required
• A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on Day 1 before first dose of study drug
• Females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from Day 1 (baseline) and continue until 30 days after the end of treatment (EOT) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)

You may not qualify if:

• Participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
• Participant has any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator
• Participant is infected/co-infected with non-genotype 4 HCV
• Participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ECG) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
• Participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (2)

Unknown Facility

Cairo, Egypt

Location

Unknown Facility

Menoufiya, Egypt

Location

Related Publications (1)

• El Raziky M, Gamil M, Ashour MK, Sameea EA, Doss W, Hamada Y, Van Dooren G, DeMasi R, Keim S, Lonjon-Domanec I, Hammad R, Hashim MS, Hassany M, Waked I. Simeprevir plus sofosbuvir for eight or 12 weeks in treatment-naive and treatment-experienced hepatitis C virus genotype 4 patients with or without cirrhosis. J Viral Hepat. 2017 Feb;24(2):102-110. doi: 10.1111/jvh.12625. Epub 2016 Oct 27.

  PMID: 27790789 DERIVED

Related Links

• A Phase2a,Partly Randomized,Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12 Week Treatment Regimen of Simeprevir in CombinationWith Sofosbuvir in Treatment-Naïve and Experienced Subjects With Chronic Genotype 4 HepatitisC Infection

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir; Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 14, 2016

Record last verified: 2016-09

Locations

EG (2)