Back to resultsٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants
Primary Purpose
Chronic Hepatitis C Virus Infection
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
SOF/SMV/DCV/RBV
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Virus Infection focused on measuring Chronic HCV GT4, Sofosbuvir, Simeprevir, Daclatasvir, Ribavirin, Experienced
Eligibility Criteria
Inclusion Criteria:
- Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments [SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV]
- Fibrosis-4 score in non-cirrhotic participants is <1.45-3.25: (None or moderate fibrosis)
- Fibrosis-4 score in cirrhotic participants is >3.25: (Advanced fibrosis or cirrhosis)
Exclusion Criteria:
- HCV coinfected with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- had any liver disease other than chronic HCV GT4 infection.
- had a history of liver decompensation
- serum a-fetoprotein (AFP) > 100 ng/ml
- evidence of hepatocellular carcinoma
- major severe illness such as respiratory, renal, heart failure or autoimmune disease
- non-compliance with treatment.
Sites / Locations
- Health Administration at Beni-Seuf
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Non-Cirrhotic
Cirrhotic
Arm Description
SOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks
SOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
Secondary Outcome Measures
Percentage of Participants With Viral relapse
Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04387539
Brief Title
ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants
Official Title
A Sofosbuvir-based Quadruple Regimen is Highly Effective in HCV Type 4-infected Egyptian Patients With DAA Treatment Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)
Detailed Description
Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.
In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus Infection
Keywords
Chronic HCV GT4, Sofosbuvir, Simeprevir, Daclatasvir, Ribavirin, Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Cirrhotic
Arm Type
Active Comparator
Arm Description
SOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks
Arm Title
Cirrhotic
Arm Type
Active Comparator
Arm Description
SOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF/SMV/DCV/RBV
Other Intervention Name(s)
Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir, Daklinza is a trade name of daclatasvir
Intervention Description
SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability.
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
Description
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs.
Time Frame
12 weeks after last dose
Title
Number of Participants With Adverse Events in Each Treatment Arm
Description
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
Time Frame
Screening up to 12 weeks after last dose
Secondary Outcome Measure Information:
Title
Percentage of Participants With Viral relapse
Description
Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.
Time Frame
Up to 12 weeks after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments [SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV]
Fibrosis-4 score in non-cirrhotic participants is <1.45-3.25: (None or moderate fibrosis)
Fibrosis-4 score in cirrhotic participants is >3.25: (Advanced fibrosis or cirrhosis)
Exclusion Criteria:
HCV coinfected with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
had any liver disease other than chronic HCV GT4 infection.
had a history of liver decompensation
serum a-fetoprotein (AFP) > 100 ng/ml
evidence of hepatocellular carcinoma
major severe illness such as respiratory, renal, heart failure or autoimmune disease
non-compliance with treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Abdel-Gabbar, Ass. Prof
Organizational Affiliation
Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Administration at Beni-Seuf
City
Bani Sweif
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29625827
Citation
Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Ramadan M. A sofosbuvir-based quadruple regimen is highly effective in HCV type 4-infected Egyptian patients with DAA treatment failure. J Hepatol. 2018 Jun;68(6):1313-1315. doi: 10.1016/j.jhep.2018.03.010. Epub 2018 Apr 3. No abstract available.
Results Reference
result
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ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants
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