HCV Infection ( Genotype 4) in CKD PatientsPhase 2/3HCV/CKDNCT07770984
Treatment of CKD Patients With HCV
A Phase 2/3 study testing SOF+DCV and OBV/PTV/r) ± ribavirin (RBV) in people with HCV Infection ( Genotype 4) in CKD Patients, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the optimal drug therapy of HCV in CKD Patients different stages with or without compensated cirrhosis. The main questions it aims to answer are: outcome measure 1: Efficacy of the treatment by the assessment of sustained virological response (SVR12) following 12 weeks… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV Infection ( Genotype 4) in CKD Patients
- What is being tested?
- SOF+DCV and OBV/PTV/r) ± ribavirin (RBV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2026to 15 May 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Both male and female.
- Adults more than 18 years.
- Patients with CKD different stages stable on treatment with or without HD.
- HD Patients should be stable for at least 6 months under regular hemodialysis.
- Clinically stable condition as outpatients.
- Patients with HCV infections (serum positive for HCV GT4 with HCV RNA>1000 IU/ml by PCR).
- White blood cells count more than 2500/mm3.
- Platelet count more than 7500/mm3.
Who cannot join
- Confirmed pregnancy.
- HCV-HIV co infection.
- HBV-HCV co infection.
- Unstable CKD patients.
- Patients who are recently stabilized on HD (less than 6 months).
- Patients on peritoneal dialysis.
- For patients without cirrhosis, Patients will be excluded if ALT or AST more than five times the upper limit of normal.
- For patients with cirrhosis, Patients will be excluded if ALT or AST are higher than seven times the upper limit of normal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee
Tanta, Gharbia Governorate, 31719
Viral committee Tanta University, +20403337544, dean@med.tanta.edu.eg
dr.ahmed.k658@gmail.com
About this study
Official title: Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV
The goal of this clinical trial is to evaluate the optimal drug therapy of HCV in CKD Patients different stages with or without compensated cirrhosis. The main questions it aims to answer are:
outcome measure 1: Efficacy of the treatment by the assessment of sustained virological response (SVR12) following 12 weeks after the last dose HCV RNA drop to undetectable levels.
Read more
outcome measure 2: Safety of the treatment by comparing the biochemical parameters before and after treatment.
If there is a comparison group: Researchers will compare biochemical parameters of the participants before and after treatment to see if there is any decline in the general health.
Participants will be divided to two groups according to their kidney status depending on their GFR, Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks, Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.
Read the detailed description
The study will be conducted on HCV patients with CKD in Tanta University Hospitals (Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee). The duration of the study will be at least 6 months for treatment and follow up.
A total number of fifty (50) chronic renal disease patients with HCV infection to be treated with the DAAs will be selected to be adjusted for age, sex, comorbid conditions, serum albumin, phosphorus and creatinine clearance and divided in two groups.
Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks. Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.
Blood samples will be collected at enrollment and periodically to evaluate the serum levels of:
- Liver Function Tests: • ALT, AST, Serum Albumin \& Serum Bilirubin.
- Kidney Function Tests: • Serum Creatinine \& Urea
- Serum Electrolytes: • Serum Calcium, Serum Potassium \& Serum Phosphorus.
- HCV RNA quantitative PCR.
- AFP for Cirrhotic Patients.
- INR.
- Parathormone (PTH) for HD Patients.
- Blood Sugar for Diabetic Patients
- CBC. Health-related quality of life measures will be assessed using KDQOL 36 survey.
Study design:
- This clinical study is non randomized, interventional, prospective and open label study groups.
- HCV status will be determined based on an established diagnosis of HCV infection or positive HCV serology at study enrollment.
- Group 1: 25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive Sofosbuvir 400mg/day and Daclatasvir 60mg/day for 12 weeks.
- Group 2: 25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg (2 Tablets Qurevo®/day) and Ribavirin 200mg for 12 weeks.
- Qurevo® will be given for Group B (on the day of dialysis, it will be given after dialysis session for the HD patients).
- Ribavirin will be given for Group B (on the day of dialysis, it will be given 4 hrs. before dialysis session for the HD patients).
- Health-related quality of life measures will be assessed using specific survey.
- Being tested
- SOF+DCV, OBV/PTV/r) ± ribavirin (RBV)
- Keywords
- CKD/HCV
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOF+DCVDrug
25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive one oral tablet of Sofosbuvir 400mg/day and one oral tablet of Daclatasvir 60mg/day for 12 weeks.
OBV/PTV/r) ± ribavirin (RBV)Drug
25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive 2 oral tablets Qurevo®/day (Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg ) and one oral capsule of Ribavirin 200mg for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HCV patients with GFR more than 30ml/min | Active comparator | 25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive one oral tablet of Sofosbuvir 400mg/day and one oral tablet of Daclatasvir 60mg/day for 12 weeks. Receives: Drug: SOF+DCV |
| HCV patients withGFR less than 30ml/min | Active comparator | 25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive 2 oral tablets Qurevo®/day (Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg ) and one oral capsule of Ribavirin 200mg for 12 weeks. Receives: Drug: OBV/PTV/r) ± ribavirin (RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
HCV eradication expressed as sustained virological response (SVR12) following 12 weeks after the last dose HvV RNA drop to undetectable levels.
Measured: 12 weeks
Secondary outcomes (1)
Treatment safety
Safety of the treatment by recording the side effects appear on the patients after 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 posted18 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV Infection ( Genotype 4) in CKD PatientsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study ia also prospective
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Mohamed El Gammalh, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770984
- Sponsor's protocol ID
- 32758/12/18
- Acronym
- HCV/CKD
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV
- ClinicalTrials.gov ID
- NCT07770984
- Acronym / sponsor ID
- HCV/CKD / 32758/12/18
- Keywords
- CKD/HCV
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 18 Aug 2026 (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.
The goal of this clinical trial is to evaluate the optimal drug therapy of HCV in CKD Patients different stages with or without compensated cirrhosis. The main questions it aims to answer are:
outcome measure 1: Efficacy of the treatment by the assessment of sustained virological response (SVR12) following 12 weeks after the last dose HCV RNA drop to undetectable levels.
outcome measure 2: Safety of the treatment by comparing the biochemical parameters before and after treatment.
If there is a comparison group: Researchers will compare biochemical parameters of the participants before and after treatment to see if there is any decline in the general health.
Participants will be divided to two groups according to their kidney status depending on their GFR, Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks, Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.
Detailed description
The study will be conducted on HCV patients with CKD in Tanta University Hospitals (Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee). The duration of the study will be at least 6 months for treatment and follow up.
A total number of fifty (50) chronic renal disease patients with HCV infection to be treated with the DAAs will be selected to be adjusted for age, sex, comorbid conditions, serum albumin, phosphorus and creatinine clearance and divided in two groups.
Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks. Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.
Blood samples will be collected at enrollment and periodically to evaluate the serum levels of:
- Liver Function Tests: • ALT, AST, Serum Albumin \& Serum Bilirubin.
- Kidney Function Tests: • Serum Creatinine \& Urea
- Serum Electrolytes: • Serum Calcium, Serum Potassium \& Serum Phosphorus.
- HCV RNA quantitative PCR.
- AFP for Cirrhotic Patients.
- INR.
- Parathormone (PTH) for HD Patients.
- Blood Sugar for Diabetic Patients
- CBC. Health-related quality of life measures will be assessed using KDQOL 36 survey.
Study design:
- This clinical study is non randomized, interventional, prospective and open label study groups.
- HCV status will be determined based on an established diagnosis of HCV infection or positive HCV serology at study enrollment.
- Group 1: 25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive Sofosbuvir 400mg/day and Daclatasvir 60mg/day for 12 weeks.
- Group 2: 25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg (2 Tablets Qurevo®/day) and Ribavirin 200mg for 12 weeks.
- Qurevo® will be given for Group B (on the day of dialysis, it will be given after dialysis session for the HD patients).
- Ribavirin will be given for Group B (on the day of dialysis, it will be given 4 hrs. before dialysis session for the HD patients).
- Health-related quality of life measures will be assessed using specific survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study ia also prospective
| Arm | Type | Receives |
|---|---|---|
| HCV patients with GFR more than 30ml/min | Active comparator | Drug: SOF+DCV25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive one oral tablet of Sofosbuvir 400mg/day and one oral tablet of Daclatasvir 60mg/day for 12 weeks. |
| HCV patients withGFR less than 30ml/min | Active comparator | Drug: OBV/PTV/r) ± ribavirin (RBV)25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive 2 oral tablets Qurevo®/day (Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg ) and one oral capsule of Ribavirin 200mg 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 (8 listed)
- Both male and female.
- Adults more than 18 years.
- Patients with CKD different stages stable on treatment with or without HD.
- HD Patients should be stable for at least 6 months under regular hemodialysis.
- Clinically stable condition as outpatients.
Key exclusion criteria (8 listed)
- Confirmed pregnancy.
- HCV-HIV co infection.
- HBV-HCV co infection.
- Unstable CKD patients.
- Patients who are recently stabilized on HD (less than 6 months).
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 |
|---|---|---|
| SOF+DCV25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive one oral tablet of Sofosbuvir 400mg/day and one oral tablet of Daclatasvir 60mg/day for 12 weeks. | Drug | HCV patients with GFR more than 30ml/min |
| OBV/PTV/r) ± ribavirin (RBV)25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive 2 oral tablets Qurevo®/day (Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg ) and one oral capsule of Ribavirin 200mg for 12 weeks. | Drug | HCV patients withGFR less than 30ml/min |
Primary outcome
Treatment efficacy
Time frame: 12 weeks
HCV eradication expressed as sustained virological response (SVR12) following 12 weeks after the last dose HvV RNA drop to undetectable levels.
1 secondary outcome
Treatment safety
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SOF+DCV and OBV/PTV/r) ± ribavirin (RBV) in people with HCV Infection ( Genotype 4) in CKD Patients, run by Tanta University 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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El Gammalh, Bsc in pharmaceutical sciences (+201128907433, dr_ahmed_k658@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.