Hepatitis cPhase 2/3NCT02483156

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

A Phase 2/3 study testing Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg, Sofosbuvir tablet (SOF) 400 mg - once daily and Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening in people with Hepatitis c, run by Egyptian Liver Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis c
What is being tested?: Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg, Sofosbuvir tablet (SOF) 400 mg - once daily and Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteEgypt
Study dates: Jul 2015to Aug 2015
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
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 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

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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:
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:
ALT ≤ 10 x the upper limit of normal (ULN)
AST ≤ 10 x ULN
Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female subjects
Platelets > 50,000 cells/mm3
INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
Albumin ≥ 3 g/dL
Direct bilirubin ≤ 1.5 x ULN
HbA1c ≤ 10%
Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
Subject has not been treated with any investigational drug or device within 30 days of the screening visit.
A female subject is eligible to enter the study if it is confirmed that she is:
Not pregnant or nursing
Of non-childbearing potential (ie, women who have had a hysterectomy, both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 50 years of age with cessation [for 12 months] of previously occurring menses), or
Of childbearing potential (ie, women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure). Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 6 months after last dose of RBV:
Complete abstinence from intercourse. Periodic abstinence from intercourse (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
Or
Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 6 months after the last dose of RBV. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone-containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control.
Intrauterine device (IUD) with a failure rate of < 1% per year
Female barrier method: cervical cap or diaphragm with spermicidal agent
Tubal sterilization
Vasectomy in male partner
All male study participants must agree to consistently and correctly use a condom, while their female partner agrees to use either 1 of the non-hormonal methods of birth control listed above or a hormone-containing contraceptive listed below, from the date of screening until 7 months after their last dose of RBV:
Implants of levonorgestrel
Injectable progesterone
Oral contraceptives (either combined or progesterone only)
Contraceptive vaginal ring
Transdermal contraceptive patch
Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV.
Subject must be of generally good health as determined by the Investigator.
Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
Willing and able to provide written informed consent.
Male or female, age ≥ 18 years.
HCV genotype 4 at screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation. Historical result from prior participation in this study is acceptable, if applicable.
Cohort 1 only: HCV RNA ≥ 104 IU/mL at screening.
Chronic HCV infection (≥ 6 months) documented by medical history.
Cohort 1 only: HCV treatment naïve, defined as no prior exposure to any IFN, RBV, or other approved or experimental HCV specific direct acting antiviral agent
BMI ≥ 18 kg/m2
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 C- Fibro Test 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.
Screening ECG without clinically significant abnormalities.
Subjects must have the following laboratory parameters at screening:
ALT ≤ 10 x the upper limit of normal (ULN)
AST ≤ 10 x ULN
Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female subjects
Platelets > 50,000 cells/mm3
INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
Albumin ≥ 3 g/dL
Direct bilirubin ≤ 1.5 x ULN
HbA1c ≤ 10%
Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
Subjects who received prior treatment in this study and who currently do not fulfill all of the above requirements may be enrolled in Part B Cohort 2 at the request of the Investigator and with the approval of the Medical Monitor or Study Director.
Subject has not been treated with any investigational drug or device within 28 days of the Baseline/Day 1 visit.
A female subject is eligible to enter the study if it is confirmed that she is:
D Not pregnant or nursing e Of non-childbearing potential (ie, women who have had a hysterectomy, both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 50 years of age with cessation [for 12 months] of previously occurring menses), or
F Of childbearing potential (ie, women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure). Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 30 days after the last dose of LDV/SOF or 6 months after last dose of RBV:
Complete abstinence from intercourse. Periodic abstinence from intercourse (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
Or
Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 30 days after the last dose of LDV/SOF or 6 months after the last dose of RBV.
Intrauterine device (IUD) with a failure rate of < 1% per year
Female barrier method: cervical cap or diaphragm with spermicidal agent
Tubal sterilization
Vasectomy in male partner
Implants of levonorgestrel
Injectable progesterone
Oral contraceptives (either combined or progesterone only)
Contraceptive vaginal ring
Transdermal contraceptive patch
All male study participants must agree to consistently and correctly use a condom from Baseline until 90 days after their last dose of LDV/SOF or 7 months after their last dose of RBV. If their female partner is of childbearing potential (as defined above), she must use 1 of the methods of birth control listed above from the date of screening until 90 days after their last dose of LDV/SOF or 7 months after their last dose of RBV.
Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV or 90 days after their last dose of LDV/SOF, as applicable.
Subject must be of generally good health as determined by the Investigator.
Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Who cannot join

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
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).

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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.
History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1.
Known hypersensitivity to RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
For treatment naïve subjects only (Cohort 1): Prior exposure to IFN, RBV, or other approved or experimental direct-acting antiviral targeting the HCV.
Current or prior history of any of the following:
A Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) B Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol, or, current evaluation for a potentially clinically significant illness (other than HCV) C Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug D Solid organ transplantation E Significant pulmonary disease, significant cardiac disease or porphyria F Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 6 months prior to Baseline/Day 1 or that has not required medication in the last 12 months may be enrolled.
G Any malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.), or current evaluation for possible malignancy H Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy I Significant drug allergy (such as anaphylaxis or hepatotoxicity)
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)
Use of any prohibited concomitant medications
Contraindication to RBV therapy, including significant history of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)
In the judgment of the investigatory, any clinically-relevant drug or alcohol abuse within 12 months of screening that may interfere with subject treatment, assessment of compliance with the protocol
Pregnant or nursing females or male with pregnant female partner
Known hypersensitivity to RBV, SOF, or formulation excipients

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Egyptian Liver Hospital
Sherbin, Dakahlia Governorate, 35516

Other trials in Egypt

About this study

Sponsor: Wadi El Nil Hospital

Study Centers Planned: Approximately 2 sites in Egypt

Read the detailed description

Study Design:

Part A

Randomized, open-label study in treatment naïve and treatment experienced adults with chronic genotype 4 HCV infection.

Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), RBV, or other approved or experimental HCV specific direct acting antivirals.

Treatment-experienced is defined as:

IFN Intolerant
Non-response
Relapse/Breakthrough

It is planned that 40 + 40 subjects will be enrolled in the study such that an approximate even number of treatment naïve and treatment experienced subjects will be enrolled across the 2 treatment arms:

Arm 1 Sofosbuvir 400 mg once daily +RBV (1000 mg/day) for 12-24 weeks

Arm 2 Single 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 Treatment assignments will be stratified according to prior treatment experience and the presence or absence of cirrhosis.

Cohorts:

Cohort is a single-arm, open-label, non-randomized design in subjects who completed treatment in Part A of the study with SOF+RBV for 12-24 weeks or in Part B of the study with single dose EHCV (2 Tablet) containing SOF/RBV/AH FDC for 12-24 weeks.

Diagnosis and Main Eligibility Criteria: HCV RNA > 104 IU/mL or HCV RNA > LLOQ and did not achieve SVR 12 after completing prior treatment in this study with chronic genotype 4 HCV infection. Treatment-naïve or treatment experienced adults, male and non-pregnant/non-lactating female subjects, ages 18 years or older. See Section 1 and 1.2 of the protocol for detailed Inclusion and Exclusion criteria.

Study Procedures/

Frequency: Study visits for all subjects will occur at screening, Baseline/Day 1. On-treatment visits will occur as follows:

Part A, Arm 1 and 2 - at the end of Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 All subjects will complete a 4-Week Post-treatment visit regardless of treatment duration. Subjects with HCV RNA < LLOQ will continue to 12 Week and 24 Week Post treatment visits unless confirmed viral relapse occurs at which time subjects will be early terminated from the study.

Screening assessments include safety laboratory tests (chemistry, hematology, coagulation, and urinalysis), 12 lead ECG, HCV RNA, serology (HBV, and HIV), hemoglobin A1c, urine drug screen, liver imaging, serum B-hCG (for all female subjects of child-bearing potential), physical examination (with height and bodyweight), vital signs, medical history, concomitant medications, and adverse events. In addition, subjects being screened for Part A and Part B (Cohort 1) will have HCV genotyping and IL28B genotyping performed.

On-treatment assessments include safety laboratory tests (chemistry, hematology, and coagulation), HCV RNA, urine pregnancy tests (for all female subjects of child-bearing potential), physical examination, vital signs, concomitant medications, and adverse events.

Post-treatment assessments include HCV RNA, urine pregnancy tests (for all female subjects of child-bearing potential), vital signs, concomitant medications, and adverse events.

Samples will be collected at Baseline/Day 1 and every visit Plasma samples will be collected during treatment visits for pharmacokinetic (PK) analysis of study drug (Part A only). Untested samples will be archived for up to 10 years.

Test Product, Dose, and Mode of Administration: 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 (1000 mg) splitted on 2 doses daily 600 mg on morning and 400 mg on evening and with food for 12-24 weeks.

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.

Reference Therapy, Dose, and Mode of Administration: None

Criteria for Evaluation:

Safety: 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. Clinical laboratory tests will be performed during treatment through the 12 Week Post-Treatment Visit.

Efficacy: Efficacy will be evaluated using scheduled assessments of HCV RNA performed using COBAS® TaqMan® HCV Test, v2.0 for Use with the High Pure System.

PK Part A only. A single PK blood sample will be collected at all study visits while on Treatment.

Statistical Methods: The primary efficacy endpoint is SVR12 (ie, HCV RNA < LLOQ 12 weeks post-treatment) in all subjects who are randomized and treated. No statistical hypothesis testing will be performed. For each of the two treatment groups, a 2-sided 95% confidence interval using the exact binomial distribution will be constructed.

Part A: With a sample size of 40 subjects in each arm, a two sided 95% exact confidence interval will extend at most 29% in length.

Part B: With a sample size of 40 subjects in each treatment group in Cohort 1, a 2-sided 95% exact confidence interval will extend at most 32% in length.

Secondary efficacy endpoints include the proportion of subjects with SVR4 and SVR24.

All continuous endpoints will be summarized using an 8 number summary (n, mean, standard deviation, and median, Q1, Q3, minimum, maximum) by treatment duration. All categorical endpoints will be summarized by number and percentage of subjects who meet the endpoint definition.

Safety endpoints will be analyzed by the number and percent of subjects with events or abnormalities for categorical values or using an 8 number summary (n, mean, standard deviation, median, Q1, Q3, minimum, maximum) for continuous data by treatment group.

Data from Part B will be analyzed separately from Part A and may be reported separately.

This study will be conducted in accordance with the guidelines of Good Clinical Practices (GCPs) including archiving of essential documents.

Conditions: Hepatitis c
Being tested: Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg, Sofosbuvir tablet (SOF) 400 mg - once daily, Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening
Keywords: HCV, Sofosbuvir, Ribavirin
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mgDrug
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.
Sofosbuvir tablet (SOF) 400 mg - once dailyDrug
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.
Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on eveningDrug
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.

Study groups in NCT02483156
Study group	Role	What they receive
SOF + RBV	Active comparator	Sofosbuvir 400 mg once daily +RBV (1000 mg/day) for 12-24 weeks Receives: Drug: Sofosbuvir tablet (SOF) 400 mg - once daily; Drug: Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening
sof + RBV + AH	Experimental	Single 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 Receives: Drug: Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 4 Week Post-Treatment Visit

Secondary outcomes (1)

Change in Circulating HCV RNA
Efficacy will be evaluated using scheduled assessments of HCV RNA performed using COBAS® TaqMan® HCV Test, v2.0 for Use with the High Pure System.
Measured: Baseline to 24 weeks after discontinuation of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Aug 2015

First posted26 Jun 2015 (estimated)
Study startJul 2015
Primary completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatitis cStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02483156
Sponsor's protocol ID: ELH - 2015
Status last verified: Oct 2016
First submitted: 19 Jun 2015
Last updated: 17 Oct 2016
Results posted: No

Publications

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.
PubMed 25937436
Shiha 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.
PubMed 33633233

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis c trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02483156
Acronym / sponsor ID: ELH - 2015
Conditions: Hepatitis c
Keywords: HCV, Sofosbuvir, Ribavirin
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Egyptian Liver HospitalUniversity, hospital or other
Collaborators: Wadi El Nil Hospital
Study start: Jul 2015
Primary completion: Aug 2015 (actual)
First posted: 26 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Sponsor: Wadi El Nil Hospital

Study Centers Planned: Approximately 2 sites in Egypt

Detailed description

Study Design:

Part A

Randomized, open-label study in treatment naïve and treatment experienced adults with chronic genotype 4 HCV infection.

Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), RBV, or other approved or experimental HCV specific direct acting antivirals.

Treatment-experienced is defined as:

IFN Intolerant
Non-response
Relapse/Breakthrough

Arm 1 Sofosbuvir 400 mg once daily +RBV (1000 mg/day) for 12-24 weeks

Cohorts:

Study Procedures/

Frequency: Study visits for all subjects will occur at screening, Baseline/Day 1. On-treatment visits will occur as follows:

Part A, Arm 1 and 2 - at the end of Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 All subjects will complete a 4-Week Post-treatment visit regardless of treatment duration. Subjects with HCV RNA < LLOQ will continue to 12 Week and 24 Week Post treatment visits unless confirmed viral relapse occurs at which time subjects will be early terminated from the study.

Post-treatment assessments include HCV RNA, urine pregnancy tests (for all female subjects of child-bearing potential), vital signs, concomitant medications, and adverse events.

Reference Therapy, Dose, and Mode of Administration: None

Criteria for Evaluation:

Efficacy: Efficacy will be evaluated using scheduled assessments of HCV RNA performed using COBAS® TaqMan® HCV Test, v2.0 for Use with the High Pure System.

PK Part A only. A single PK blood sample will be collected at all study visits while on Treatment.

Part A: With a sample size of 40 subjects in each arm, a two sided 95% exact confidence interval will extend at most 29% in length.

Part B: With a sample size of 40 subjects in each treatment group in Cohort 1, a 2-sided 95% exact confidence interval will extend at most 32% in length.

Secondary efficacy endpoints include the proportion of subjects with SVR4 and SVR24.

Data from Part B will be analyzed separately from Part A and may be reported separately.

This study will be conducted in accordance with the guidelines of Good Clinical Practices (GCPs) including archiving of essential documents.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SOF + RBV	Active comparator	Drug: Sofosbuvir tablet (SOF) 400 mg - once daily, Drug: Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on eveningSofosbuvir 400 mg once daily +RBV (1000 mg/day) for 12-24 weeks
sof + RBV + AH	Experimental	Drug: Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mgSingle 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (90 listed)

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
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:

Key exclusion criteria (31 listed)

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mgThe 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.	Drug	sof + RBV + AH
Sofosbuvir tablet (SOF) 400 mg - once dailySOF 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.	Drug	SOF + RBV
Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on eveningRBV (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.	Drug	SOF + RBV

Primary outcome

Percentage of Participants Who Experienced Adverse Events During Treatment Period
Time frame: Baseline to 4 Week Post-Treatment Visit
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.

1 secondary outcome

Change in Circulating HCV RNA
Time frame: Baseline to 24 weeks after discontinuation of therapy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
Background: PubMed 25937436Doss 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.
Derived from this study: PubMed 33633233Shiha 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.
Egyptian Liver Hospital siteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 90 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experienced Adverse Events During Treatment Period (time frame: Baseline to 4 Week Post-Treatment Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02483156, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.