Hepatitis CPhase 3NCT03186313
A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection
A Phase 3 study testing Dactavira Plus, Sofosbuvir + Daclatasvir + Ribavirin and Dactavira in people with Hepatitis C, run by Egyptian Liver Hospital at 1 site in Egypt.
Trial summary
A phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the combined single dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir \& Ribavirin) versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a single dose of Dactavira (EPGCG, Sofosbuvir \& Daclatasvir) versus Sofosbuvir + Daclatasvir… 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?
- Dactavira Plus, Sofosbuvir + Daclatasvir + Ribavirin and Dactavira
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2016to 30 Nov 2017
- Phase
- Phase 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
None listed.
Who cannot join
- 1.2.1. Exclusion Criteria for Part A Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- Prior exposure to IFN, Ribavirin, 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 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- 5. Contraindication to Ribavirin therapy e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
Show all 27Show fewer
- 6. 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.
- 7. Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day).
- 8. 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.
- 9. History of solid organ transplantation. 10. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).
- 11. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- 12. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
- 13. History of significant pulmonary disease, significant cardiac disease or porphyria.
- 14. 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.
- 16. Known hypersensitivity to Ribavirin, the study investigational medicinal product, the metabolites, or formulation excipients.
- 1.2.2. Exclusion Criteria for Part B Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- Prior exposure to IFN, Ribavirin, or other approved or experimental direct-acting antiviral targeting the HCV.
- Current or prior history of any of the following:
- a Clinically 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.
- 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 Ribavirin 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 Sofosbuvir, or formulation excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir & Ribavirin) Versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a Single Dose of Dactavira (EPGCG, Sofosbuvir & Daclatasvir) Versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults With Chronic Genotype 4 HCV Infection
A phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the combined single dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir \& Ribavirin) versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a single dose of Dactavira (EPGCG, Sofosbuvir \& Daclatasvir) versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults with Chronic Genotype 4 HCV Infection.
Read the detailed description
Study Design: Part A Randomized, open-label study in treatment naïve cirrhotic adults with chronic genotype 4 HCV infection.
Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), Ribavirin, or other approved or experimental HCV specific direct acting antivirals.
It is planned that 28 subjects will be enrolled in the study such that an approximate even number of treatment naïve subjects will be enrolled across the 2 treatment arms:
Arm 1 Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks.
Arm 2 Daily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks.
Treatment assignments will be stratified according to the presence or absence of cirrhosis.
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 adults, male and non pregnant/non-lactating female subjects, ages 18 years or older.
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, 8, 12.
- All subjects will complete a 4-Week Post-treatment visit regardless of treatment duration. Subjects with HCV RNA < LLOQ will continue to 12 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, 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.
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.
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 Gene Xpert HCV Test.
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.
All continuous endpoints will be summarized using an 8 number summary (n, mean, standard deviation, 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.
This study will be conducted in accordance with the guidelines of Good Clinical Practices (GCPs) including archiving of essential documents.
Study Design: Part B
Randomized, open-label study in treatment naïve not cirrhotic adults with chronic genotype 4 HCV infection.
Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), Ribavirin, or other approved or experimental HCV specific direct acting antivirals.
It is planned that 50 subjects will be enrolled in the study such that an approximate even number of treatment naïve subjects will be enrolled across the 2 treatment arms:
Arm 3 Single daily dose (1 Tablets) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks.
Arm 4 Daily dose including Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks
Treatment assignments will be stratified according to the presence or absence of cirrhosis.
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 adults, male and non pregnant/non-lactating female subjects, ages 18 years or older.
Study Procedures/
Frequency: Study visits for all subjects will occur at screening, Baseline/Day 1. On-treatment visits will occur as follows:
At the end of Weeks 1, 2, 4, 8, 12.
All subjects will complete a 4-Week Post-treatment visit regardless of treatment duration. Subjects with HCV RNA < LLOQ will continue to 12 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, 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.
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.
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 Gene Xpert HCV Test.
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.
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.
- Conditions
- Hepatitis C
- Being tested
- Dactavira Plus, Sofosbuvir + Daclatasvir + Ribavirin, Dactavira, Sofosbuvir + Daclatasvir
- 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.
Dactavira PlusDrug
1 Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks.
Sofosbuvir + Daclatasvir + RibavirinDrug
Daily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks.
DactaviraDrug
Single daily dose (1 Tablet) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks
Sofosbuvir + DaclatasvirDrug
Daily dose Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Part A: Arm 1 | Experimental | Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks. Receives: Drug: Dactavira Plus |
| Part A: Arm 2 | Active comparator | Daily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks.
Treatment assignments will be stratified according to the presence or absence of cirrhosis. Receives: Drug: Sofosbuvir + Daclatasvir + Ribavirin |
| Part B: Arm 3 | Experimental | Single daily dose (1 Tablet) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks. Receives: Drug: Dactavira |
| Part B: Arm 4 | Active comparator | Daily dose including Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks. Receives: Drug: Sofosbuvir + Daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is SVR12 (ie, HCV RNA < LLOQ 12 weeks post-treatment)
The primary efficacy endpoint is SVR12 (ie, HCV RNA < LLOQ 12 weeks post-treatment)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startSep 2016
- Primary completionMay 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Liver Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wadi El Nil Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186313
- Sponsor's protocol ID
- ELH - 2016
- Status last verified
- Dec 2017
- First submitted
- 31 May 2017
- Last updated
- 27 Dec 2017
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir & Ribavirin) Versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a Single Dose of Dactavira (EPGCG, Sofosbuvir & Daclatasvir) Versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults With Chronic Genotype 4 HCV Infection
- ClinicalTrials.gov ID
- NCT03186313
- Acronym / sponsor ID
- ELH - 2016
- Conditions
- Hepatitis C
- Keywords
- HCV, Sofosbuvir, Ribavirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Egyptian Liver HospitalUniversity, hospital or other
- Collaborators
- Wadi El Nil Hospital
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- 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.
A phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the combined single dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir \& Ribavirin) versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a single dose of Dactavira (EPGCG, Sofosbuvir \& Daclatasvir) versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults with Chronic Genotype 4 HCV Infection.
Detailed description
Study Design: Part A Randomized, open-label study in treatment naïve cirrhotic adults with chronic genotype 4 HCV infection.
Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), Ribavirin, or other approved or experimental HCV specific direct acting antivirals.
It is planned that 28 subjects will be enrolled in the study such that an approximate even number of treatment naïve subjects will be enrolled across the 2 treatment arms:
Arm 1 Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks.
Arm 2 Daily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks.
Treatment assignments will be stratified according to the presence or absence of cirrhosis.
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 adults, male and non pregnant/non-lactating female subjects, ages 18 years or older.
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, 8, 12.
- All subjects will complete a 4-Week Post-treatment visit regardless of treatment duration. Subjects with HCV RNA < LLOQ will continue to 12 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, 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.
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.
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 Gene Xpert HCV Test.
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.
All continuous endpoints will be summarized using an 8 number summary (n, mean, standard deviation, 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.
This study will be conducted in accordance with the guidelines of Good Clinical Practices (GCPs) including archiving of essential documents.
Study Design: Part B
Randomized, open-label study in treatment naïve not cirrhotic adults with chronic genotype 4 HCV infection.
Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), Ribavirin, or other approved or experimental HCV specific direct acting antivirals.
It is planned that 50 subjects will be enrolled in the study such that an approximate even number of treatment naïve subjects will be enrolled across the 2 treatment arms:
Arm 3 Single daily dose (1 Tablets) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks.
Arm 4 Daily dose including Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks
Treatment assignments will be stratified according to the presence or absence of cirrhosis.
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 adults, male and non pregnant/non-lactating female subjects, ages 18 years or older.
Study Procedures/
Frequency: Study visits for all subjects will occur at screening, Baseline/Day 1. On-treatment visits will occur as follows:
At the end of Weeks 1, 2, 4, 8, 12.
All subjects will complete a 4-Week Post-treatment visit regardless of treatment duration. Subjects with HCV RNA < LLOQ will continue to 12 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, 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.
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.
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 Gene Xpert HCV Test.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Arm 1 | Experimental | Drug: Dactavira PlusSingle daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks. |
| Part A: Arm 2 | Active comparator | Drug: Sofosbuvir + Daclatasvir + RibavirinDaily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks. Treatment assignments will be stratified according to the presence or absence of cirrhosis. |
| Part B: Arm 3 | Experimental | Drug: DactaviraSingle daily dose (1 Tablet) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks. |
| Part B: Arm 4 | Active comparator | Drug: Sofosbuvir + DaclatasvirDaily dose including Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (27 listed)
- 1.2.1. Exclusion Criteria for Part A Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- Prior exposure to IFN, Ribavirin, 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 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| Dactavira Plus1 Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks. | Drug | Part A: Arm 1 |
| Sofosbuvir + Daclatasvir + RibavirinDaily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks. | Drug | Part A: Arm 2 |
| DactaviraSingle daily dose (1 Tablet) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks | Drug | Part B: Arm 3 |
| Sofosbuvir + DaclatasvirDaily dose Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks | Drug | Part B: Arm 4 |
Primary outcome
The primary efficacy endpoint is SVR12 (ie, HCV RNA < LLOQ 12 weeks post-treatment)
Time frame: 12 weeks
The primary efficacy endpoint is SVR12 (ie, HCV RNA < LLOQ 12 weeks post-treatment)
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 27 Dec 2017.
- 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.
- 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?
A Phase 3 study testing Dactavira Plus, Sofosbuvir + Daclatasvir + Ribavirin and Dactavira in people with Hepatitis C, run by Egyptian Liver Hospital at 1 site in Egypt.
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 0 inclusion and 27 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 27 Dec 2017. 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 phase mean?
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?
The primary efficacy endpoint is SVR12 (ie, HCV RNA < LLOQ 12 weeks post-treatment) (time frame: 12 weeks). 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 NCT03186313, which also lists 1 linked publication.
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 27 Dec 2017.