Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection
1 other identifier
interventional
80
1 country
1
Brief Summary
Two Groups of Genotype 4 HCV Patients will participate through open-label randomized Study comparing Sofosbuvir tablet Plus Ribavirin tablet (Part A) versus single Dose (2 tablets) of EHCV containing Sofosbuvir, Ribavirin, and Natural anti-hemolytic (B) evaluating the safety and efficacy for both arms. Sponsor: Wadi El Nil Hospital Study Centers Planned: Approximately 2 sites in Egypt
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedOctober 17, 2016
October 1, 2016
1 month
June 19, 2015
October 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced Adverse Events During Treatment Period
Adverse events will be collected from baseline through the 4 Week Post-Treatment Visit and AEs related to study procedures, will be collected from when subjects sign the consent form.
Baseline to 4 Week Post-Treatment Visit
Secondary Outcomes (1)
Change in Circulating HCV RNA
Baseline to 24 weeks after discontinuation of therapy
Other Outcomes (1)
Change in the circulating Non-genetic biomarkers
Baseline to 24 week ( treatment period)
Study Arms (2)
SOF + RBV
ACTIVE COMPARATORSofosbuvir 400 mg once daily +RBV (1000 mg/day) for 12-24 weeks
sof + RBV + AH
EXPERIMENTALSingle Dose (2 tablets) once daily each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg for 12-24 weeks
Interventions
The fixed dose EHCV combinations in Single Dose (2 tablets) once daily each tablet containing SOF 200 mg, RBV 500 mg, and Natural anti-hemolytic (AH) at 200 mg. Subjects will take 2 tablet with food for 12-24 weeks.
SOF is manufactured as a 400 mg tablet for oral administration. Subjects will take 1 tablet for a total dose of 400 mg orally once daily in the morning with RBV and with food for 12-24 weeks.
RBV (1000 mg.) splitted on 2 doses daily - 600 mg on morning and 400 mg on evening with SOF and with food for 12-24 weeks.
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent.
- Male or female, age ≥ 18 years.
- HCV RNA ≥ 104 IU/mL at screening.
- Confirmed chronic HCV infection as documented by either:
- a. a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or
- HCV genotype 4 at screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation.
- The subject's medical records must be sufficient to categorize prior treatment history as one of the following:
- i) IFN-intolerant: subject had documented intolerance to IFN during prior IFN therapy of up to 12 weeks duration ii) Non-response: subject did not achieve undetectable HCV RNA levels on treatment iii) Relapse/Breakthrough: subject achieved undetectable HCV RNA levels during treatment or within 4 weeks after treatment and later showed detectable HCV RNA
- An Absence of cirrhosis is defined as any one of the following:
- Liver biopsy within 2 years of Screening showing absence of cirrhosis
- Fibroscan with a result of ≤ 12.5 kPa within 6 months of Baseline/Day1
- FibroTest score of ≤ 0.48 AND APRI of ≤ 1 performed during Screening In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or Fibro Test.
- Body mass index (BMI) ≥ 18 kg/m2.
- Screening ECG without clinically significant abnormalities.
- Subjects must have the following laboratory parameters at screening:
- +71 more criteria
You may not qualify if:
- for treatment naïve subjects only: Prior exposure to IFN, RBV, or other approved or experimental direct-acting antiviral targeting the HCV.
- for treatment-experienced subjects: prior exposure to a NS5a inhibitor, NS5b nucleotide inhibitor, or NS5b non-nucleotide inhibitor targeting the HCV
- Pregnant or nursing female or male with pregnant female partner.
- Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis).
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- Contraindication to RBV therapy e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
- History of malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for malignancy are not eligible.
- Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent \> 10 mg/day).
- Clinically-relevant drug or alcohol abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription should be approved by the investigator.
- History of solid organ transplantation.
- Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
- History of significant pulmonary disease, significant cardiac disease or porphyria.
- Excessive alcohol ingestion, defined as 3 glasses/day (1 glass is equivalent to 284 mL beer, 125 mL wine, or 25 mL distilled spirits) for females and 4 glasses/day for males.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Egyptian Liver Hospitallead
- Wadi El Nil Hospitalcollaborator
Study Sites (1)
Egyptian Liver Hospital
Sherbin, Dakahlia Governorate, 35516, Egypt
Related Publications (2)
Doss W, Shiha G, Hassany M, Soliman R, Fouad R, Khairy M, Samir W, Hammad R, Kersey K, Jiang D, Doehle B, Knox SJ, Massetto B, McHutchison JG, Esmat G. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol. 2015 Sep;63(3):581-5. doi: 10.1016/j.jhep.2015.04.023. Epub 2015 May 1.
PMID: 25937436BACKGROUNDShiha G, Soliman R, Elbasiony M, Darwish NHE, Mousa SA. Novel combined single dose anti-hepatitis C therapy: a pilot study. Sci Rep. 2021 Feb 25;11(1):4623. doi: 10.1038/s41598-021-84066-3.
PMID: 33633233DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Clinical and Research Laboratory & Head of Molecular Biology Unit.
Study Record Dates
First Submitted
June 19, 2015
First Posted
June 26, 2015
Study Start
July 1, 2015
Primary Completion
August 1, 2015
Last Updated
October 17, 2016
Record last verified: 2016-10