Hepatitis C Genotype 4Phase 4NCT03743727
Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir
A Phase 4 study testing Combined therapy LDV and SOF in people with Hepatitis C Genotype 4, run by Yassin Abdelghaffar Charity Center for Liver Disease and Research at 1 site in Egypt.
Trial summary
This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Hepatitis C Genotype 4
- What is being tested?
- Combined therapy LDV and SOF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 30 Jun 2019
- Phase
- Phase 4
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HCV chronic infection
- Treatment naive and treatment experienced (previous interferon treatment)
- No cirrhosis or compensated cirrhosis
Who cannot join
- Co-infection with Hepatitis B (HBV)
- Other associated chronic liver illness
- Patients with history of hematemesis (non-cirrhotic portal hypertension)
- Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan)
- Patients on drugs known to interact unfavorably (Amioidarone, ..)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
Madīnat an Naşr, Cairo Governorate
Mamdouh A. Ahmed, 02-01221707770, dr.yassinabdelghaffar@gmail.com
About this study
Official title: The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.
- Conditions
- Hepatitis C Genotype 4
- Being tested
- Combined therapy LDV and SOF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined therapy LDV and SOFDrug
Also called ledipasvir and sofosbuvir
All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg).
| Study group | Role | What they receive |
|---|---|---|
| Combined Therapy LDV and SOF | Experimental | Not described Receives: Drug: Combined therapy LDV and SOF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
The presence of any adverse effects will be used to characterize this outcome measure.
Measured: During the 12 weeks of treatment.
Sustained Viral Clearance
HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.
Measured: At Week 12 after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Aug 2018
- Primary completion30 Mar 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Genotype 4Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yassin Abdelghaffar Charity Center for Liver Disease and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tawhida Yassin Abdel Ghaffar, Yassin Abdelghaffar Charity Center for Liver Disease and Research
- Investigators
- Tawhida Y. Abdel Ghaffar, MD, Principal investigator, Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743727
- Sponsor's protocol ID
- LDV SOF T 2018
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
- ClinicalTrials.gov ID
- NCT03743727
- Acronym / sponsor ID
- LDV SOF T 2018
- Conditions
- Hepatitis C Genotype 4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Yassin Abdelghaffar Charity Center for Liver Disease and ResearchUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 16 Nov 2018 (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.
This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Therapy LDV and SOF | Experimental | Drug: Combined therapy LDV and SOF |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- HCV chronic infection
- Treatment naive and treatment experienced (previous interferon treatment)
- No cirrhosis or compensated cirrhosis
Key exclusion criteria (5 listed)
- Co-infection with Hepatitis B (HBV)
- Other associated chronic liver illness
- Patients with history of hematemesis (non-cirrhotic portal hypertension)
- Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan)
- Patients on drugs known to interact unfavorably (Amioidarone, ..)
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 |
|---|---|---|
| Combined therapy LDV and SOFAlso: ledipasvir and sofosbuvirAll patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg). | Drug | Combined Therapy LDV and SOF |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: During the 12 weeks of treatment.
The presence of any adverse effects will be used to characterize this outcome measure.
Sustained Viral Clearance
Time frame: At Week 12 after end of treatment.
HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C Genotype 4
Not yet recruitingPhase 2/3
Treatment of CKD Patients With HCV
HCV Infection ( Genotype 4) in CKD Patients
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.
Tawhida Y. Abdel Ghaffar, MD principal investigator
Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined therapy LDV and SOF in people with Hepatitis C Genotype 4, run by Yassin Abdelghaffar Charity Center for Liver Disease and Research 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Nov 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mamdouh A. Ahmed (02-01221707770, dr.yassinabdelghaffar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: During the 12 weeks of treatment.). The study lists 2 primary outcomes in all. 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 16 Nov 2018.