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Report for Clinical Trial NCT02032888

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)

A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.

NCT02032888 Hepatitis C
MeSH:Hepatitis A Hepatitis C Hepatitis
HPO:Hepatitis

2 Interventions

Name: Daclatasvir

Type: Drug
Group Labels: 3

Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks

Name: Sofosbuvir

Type: Drug
Group Labels: 3

Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks


Primary Outcomes

Description: SVR12 was defined as HCV RNA Measure: Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

Time: At follow-up Week 12

Secondary Outcomes

Description: SVR12 was defined as HCV RNA Measure: Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

Time: At follow-up Week 12

Description: SVR12 was defined as HCV RNA Measure: Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

Time: At follow-up Week 12

Description: SVR12 was defined as HCV RNA levels Measure: Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)

Time: At follow-up Week 12

Description: Participants with hepatitis C virus CV) levels to be Measure: Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be Time: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24


Description: Participants with HCV RNA levels Measure: Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels Time: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment


Description: SVR is defined as hepatitis C virus RNA Measure: Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)

Time: At Follow-up Week 12

Description: AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period

Time: AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)

Description: AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period

Time: AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.

Description: Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4.

Measure: Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results

Time: From screening up to week 24 of post treatment follow--up

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.. Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12).



HPO Nodes


HPO: