The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

Hepatitis C Clinical Trial

Official title:

The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580474
• Other study ID #: AI447-118
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• HCV RNA Positive and Genotype 1b

• No history or signs or symptoms of decompensated liver disease or hepatocellular carcinoma within 6 months

• A patient who is on dialysis, or if not MDRD eGFR<30ml/min

• 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

• No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H

Exclusion Criteria:

• A patient who having received Daclatasvir or Asunaprevir

• Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study

• Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV

• Diagnosed or suspected hepatocellular carcinoma or other malignancies

• Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)

• Received solid organ or bone marrow transplant

• Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance

• Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator

• Known hypersensitivity to study drugs, metabolites, or formulation excipients

• Who has taken investigational drugs within 2 months.

Related Conditions & MeSH terms

• Hepatitis C
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Daclatasvir plus Asunaprevir

Locations

Country	Name	City	State
Korea, Republic of	Myeong Jun Song	Daejeon

Sponsors (13)

Lead Sponsor	Collaborator
Myeong Jun Song	Bristol-Myers Squibb, Cheongju St. Mary's Hospital, Cheongju, Korea, Chungnam National University Hospital, Dankook University, Eulji General Hospital, Eulji University Hospital, Konkuk University Hospital, Konyang University Hospital, Korea University Guro Hospital, Saint Vincent's Hospital, Korea, Severance Hospital, Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment		36 Week
Secondary	To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment		36 Week
Secondary	Percentage of subjects with ALT normalization at each visit from the baseline		4, 12, 24, 36 week
Secondary	Change in HCV RNA at each visit from the baseline		4, 12, 24, 36 week
Secondary	Percentage of subjects who experience viral breakthrough at each visit from the baseline		4, 12, 24, 36 week
Secondary	Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from		4, 12, 24, 36 week