Back to resultsOmbitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4
Primary Purpose
Hepatitis C Virus Infection
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
OBV/PTV/r) ± ribavirin (RBV)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring Ombitasvir, Paritaprevir, Ritonavir, Ribavirin, HCV, Genotype 4, Naïve, Egyptians
Eligibility Criteria
Inclusion Criteria:
Treatment-naïve patients with HCV GT4 with plasma HCV RNA level >10,000 IU/ml
Exclusion Criteria:
- Hepatitis of non-HCV cause
- Coinfection with other than HCV GT4
- Poorly controlled diabetics (HbA1C >8) patients
- a history of extra-hepatocellular malignancy in the last 5 years
- Major severe illness such as congestive heart failure, respiratory failure, evidence of hepatic decompensation.
- Laboratory and blood picture abnormalities such as anemia (hemoglobin concentration of 10 <g/dl) and thrombocytopenia (platelets <50,000 cells/mm3) and (serum albumin <2.8 g/dL, international normalized ratio (INR) of > 2.3, serum total bilirubin concentration of >3.0 mg/dL.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
2 DAA (OBV/PTV/r) ± ribavirin (RBV)
Arm Description
Administering Ombitasvir/Paritaprevir/Ritonavir/ tablets plus RBV tablets to HCV GT4 in the treatment of Egyptian naïve patients
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 12 IU/mL 12 weeks after the last dose of study drug.
adverse event (AE)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation observed after administering a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in, death, participant hospitalization, life-threatening, significant disability/incapacity, or a congenital anomaly.
Secondary Outcome Measures
Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment
Post-treatment relapse was defined as defined as confirmed HCV RNA > 12 IU/ml between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < 12 IU/ml at the end of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04378608
Brief Title
Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4
Official Title
Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
September 8, 2017 (Actual)
Study Completion Date
September 8, 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
The objective of the investigators was to delineate the efficacy and safety of Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian naïve patients
Detailed Description
Direct-acting antivirals (DAAs) combination therapies from various mechanisms of action and families have been revolutionized the management landscape of chronic hepatitis C virus (HCV). Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection. Here, investigators' objective was to delineate the efficacy and safety of OBV/PTV/r plus RBV of HCV GT4 in the treatment of Egyptian naïve patients.
Between 5 January and 8 September 2017, a cohort of 100 Egyptian patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV, for 12 weeks, which given as oral tablets based on patient tolerability. The primary endpoint of investigators' study was a sustained virological response (HCV RNA < 12 IU/mL) 12 weeks from the cessation of the treatment (SVR12).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
Ombitasvir, Paritaprevir, Ritonavir, Ribavirin, HCV, Genotype 4, Naïve, Egyptians
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
100 Egyptian naive patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV which given as oral tablets based on patient tolerability
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 DAA (OBV/PTV/r) ± ribavirin (RBV)
Arm Type
Other
Arm Description
Administering Ombitasvir/Paritaprevir/Ritonavir/ tablets plus RBV tablets to HCV GT4 in the treatment of Egyptian naïve patients
Intervention Type
Drug
Intervention Name(s)
OBV/PTV/r) ± ribavirin (RBV)
Other Intervention Name(s)
Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Ombitasvir (ABT 267) is an NS5A inhibitor
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Description
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 12 IU/mL 12 weeks after the last dose of study drug.
Time Frame
12 weeks after last dose
Title
adverse event (AE)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation observed after administering a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in, death, participant hospitalization, life-threatening, significant disability/incapacity, or a congenital anomaly.
Time Frame
Screening up to 30 days after last dose
Secondary Outcome Measure Information:
Title
Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment
Description
Post-treatment relapse was defined as defined as confirmed HCV RNA > 12 IU/ml between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < 12 IU/ml at the end of treatment.
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:
Treatment-naïve patients with HCV GT4 with plasma HCV RNA level >10,000 IU/ml
Exclusion Criteria:
Hepatitis of non-HCV cause
Coinfection with other than HCV GT4
Poorly controlled diabetics (HbA1C >8) patients
a history of extra-hepatocellular malignancy in the last 5 years
Major severe illness such as congestive heart failure, respiratory failure, evidence of hepatic decompensation.
Laboratory and blood picture abnormalities such as anemia (hemoglobin concentration of 10 <g/dl) and thrombocytopenia (platelets <50,000 cells/mm3) and (serum albumin <2.8 g/dL, international normalized ratio (INR) of > 2.3, serum total bilirubin concentration of >3.0 mg/dL.
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29546644
Citation
Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty M, Ramadan M. Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients. Dig Dis Sci. 2018 May;63(5):1341-1347. doi: 10.1007/s10620-018-5005-8. Epub 2018 Mar 15.
Results Reference
background
Links:
URL
https://doi.org/10.1007/s10620-018-5005-8
Description
This link clarify the retreatment efficacy and safety of SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens
Learn more about this trial
Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4
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