An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

NCT02397395 | Withdrawn Phase 2

• 3 other identifiers: CR106396TMC435HPC20182014-004250-34
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)

Conditions

Renal Impairment; End-stage Renal Disease

Keywords

Renal Impairment; End-stage Renal Disease; Simeprevir; Daclatasvir

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) , detectable or undetectable at 12 weeks after EOT.

  12 weeks after end of treatment (EOT) (Week 12 of follow-up phase)

Secondary Outcomes (7)

• Percentage of Participants With On-treatment Response

  Baseline up to EOT (Week 12)

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

  4 weeks after EOT (Week 4 of follow-up phase)

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

  24 weeks after EOT (Week 24 of follow-up phase)

• Percentage of Participants With on-treatment Failure

  Baseline up to EOT (Week 12), 12 weeks after EOT (Week 12 of follow-up phase)

• Percentage of Participants With Viral Relapse

  EOT (Week 12) until end of follow-up phase (Week 24 of follow-up phase)

Study Arms (1)

Simeprevir Co-administered with Daclatasvir

EXPERIMENTAL

All participants will receive Simeprevir (SMV) 150 milligram (mg) capsule co-administered with Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks. Participants should take the study drugs (SMV and DCV together) orally and once daily with food.

Drug: Simeprevir (SMV) 150 mg; Drug: Daclatasvir (DCV) 60 mg

Interventions

Simeprevir (SMV) 150 mg DRUG

Simeprevir (SMV) 150 milligram (mg) capsule orally, once daily for a duration of 12 weeks.

Simeprevir Co-administered with Daclatasvir

Daclatasvir (DCV) 60 mg DRUG

Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks.

Simeprevir Co-administered with Daclatasvir

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman, between 18 and 70 years of age, inclusive, at screening
• Hepatitis C Virus (HCV genotype): HCV genotype 1b or 4 (determined at screening)
• Plasma HCV RNA: Greater than (\>) 10,000 international unit per milliliter (IU/mL) (determined at screening)
• HCV disease status: FibroScan less than (\<) 14.5 kilopascal (kPa), performed within 3 months prior to screening, or between screening and baseline (Day 1), and no history or signs or symptoms of decompensated liver disease. In participants with FibroScan \>12.5 kPa, absence of findings suspicious for hepatocellular carcinoma documented by an abdominal ultrasound, performed within 3 months prior to screening, or between screening and baseline (Day 1)
• HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon (\[Peg\]IFN)-based drug regimen (with or without ribavirin \[RBV\] and not including a direct-acting antiviral agent \[DAA\]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening

You may not qualify if:

• Infection/co-infection: HCV genotype other than 1b or 4, Human immunodeficiency virus type 1 or 2
• Liver disease of non-HCV etiology: Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, hepatitis B (hepatitis B surface antigen positive), 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
• Hepatic decompensation: History or evidence of clinical hepatic decompensation (presence of ascites, bleeding varices or hepatic encephalopathy)
• Organ transplantation/renal replacement therapy: Prior organ transplant (other than cornea, hair transplant or skin graft), except for history of kidney transplant with subsequent renal failure requiring hemodialysis and for which use of immunosuppressants has been discontinued; Considered for kidney transplant or imminent renal replacement therapy (including intermittent hemodialysis; continuous hemofiltration and hemodialysis; and peritoneal dialysis) for participants with severe renal impairment within a time frame that overlaps with study participation
• Key protocol defined laboratory abnormalities

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (6)

Unknown Facility

Paris, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Santander, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Interventions

Simeprevir; daclatasvir

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen R&D Ireland Clinical Trial

  Janssen R&D Ireland

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 25, 2015
• Study Start: May 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

FR (3); ES (3)