Clinical trial NCT02580474: The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
Official title: The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Soonchunhyang University Hospital
name: Dankook University
name: Chungnam National University Hospital
name: Konyang University Hospital
name: Eulji University Hospital
name: Saint Vincent's Hospital, Korea
name: Konkuk University Hospital
name: Cheongju St. Mary's Hospital, Cheongju, Korea
name: Severance Hospital
name: Korea University Guro Hospital
name: Eulji General Hospital
First posted: 2015-10-20
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment
timeFrame: 36 Week
Secondary outcomes:
measure: To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment
timeFrame: 36 Week
measure: Percentage of subjects with ALT normalization at each visit from the baseline
timeFrame: 4, 12, 24, 36 week
measure: Change in HCV RNA at each visit from the baseline
timeFrame: 4, 12, 24, 36 week
measure: Percentage of subjects who experience viral breakthrough at each visit from the baseline
timeFrame: 4, 12, 24, 36 week
measure: Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from
timeFrame: 4, 12, 24, 36 week
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Myeong Jun Song
Study officials:
References:
citation: Lee BS, Song MJ, Kwon JH, Lee TH, Jang JW, Kim SH, Lee SH, Kim HS, Kim JH, Kim SB, Ko SY, Song DS. Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis. Gut Liver. 2019 Mar 15;13(2):191-196. doi: 10.5009/gnl18240.