An open-label single arm study to evaluate the safety and efficacy of 12-week simeprevir/peginterferon alpha-2a/ribavirin treatment in patients with chronic genotype 1 HCV infection

An open-label single arm study to evaluate the safety and efficacy of 12-week simeprevir/peginterferon alpha-2a/ribavirin treatment in patients with chronic genotype 1 HCV infection - A study of 12-week simeprevir/peginterferon alpha-2a/ribavirin treatment for chronic genotype 1 HCV infection (LINK study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012661

Enrollment

160

Registered

2013-12-24

Start date

2013-12-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis C

Interventions

simeprevir, pegylated interferon alfa-2a, ribavirin Patients will receive 12-week simeprevir/peginterferon alfa-2a/ribavirin treatment. If serum HCV-RNA is undetectable at weeks 2, 4 and 8, all treat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infected with genotype 1 (1a or 1b) HCV 2. Serum HCV-RNA levels greater than 5 logIU/mL 3. Untreated or relapsed after treatment of (peg)interferon with or without ribavirin 4. WBC count of 3000/microL or higher, neutrophil count of 1500/microL or higher, platelet count of 90000/microL or higher, and hemoglobin count of 12 g/dl or higher within 30 days prior to entry into the study

Exclusion criteria

Exclusion criteria: 1. patients who received treatments containing telaprevir 2. pregnant women 3. patients allergic to ribavirin or IFN 4. patients with uncontrolled heart diseases 5. patients with abnormal hemoglobin 6. patients with chronic renal diseases 7. patients with severe depression or mental illness 8. patients with liver cirrhosis or liver failure 9. patients who cannot discontinue other antiviral or immunomodulating drugs

Design outcomes

Primary

Measure	Time frame
The percentage of patients with a sustained virologic response 12 weeks after planned end of treatment (SVR12)	—

Secondary

Measure	Time frame
1. The percentage of patients with a sustained virologic response 24 weeks after planned end of treatment (SVR24). 2. The percentage of patients whose serum HCV-RNA is undetectable at weeks 2, 4, 8, 12, 24, 36, and 48. 3. The percentage of relapsers. 4. The percentage of patients with breakthrough. 5. The percentage of patients who meet stopping criteria. 6. The percentage of patients who have adverse effects. 7. Relationship between IL-28B SNP and efficacy. 8. Relationship between HCV core 70 variants and efficacy. 9. Relationship between SNPs of SLCO1B1 and SLCO1B3, and simeprevir-induced hyperbilirubinemia. 10. Analysis of HCV variants resistant to simeprevir in breakthrough cases.	—

Measure

Time frame

1. The percentage of patients with a sustained virologic response 24 weeks after planned end of treatment (SVR24). 2. The percentage of patients whose serum HCV-RNA is undetectable at weeks 2, 4, 8, 12, 24, 36, and 48. 3. The percentage of relapsers. 4. The percentage of patients with breakthrough. 5. The percentage of patients who meet stopping criteria. 6. The percentage of patients who have adverse effects. 7. Relationship between IL-28B SNP and efficacy. 8. Relationship between HCV core 70 variants and efficacy. 9. Relationship between SNPs of SLCO1B1 and SLCO1B3, and simeprevir-induced hyperbilirubinemia. 10. Analysis of HCV variants resistant to simeprevir in breakthrough cases.

—

Countries

Japan

Contacts

Public ContactTatehiro Kagawa

Tokai University School of Medicine Division of Gastroenterology, Department of Internal Medicine

kagawa@tokai.ac.jp81-463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026