Hepatitis C Virus Infection, Response to Therapy ofPhase 3NCT03343444
Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents
A Phase 3 study testing 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) and 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) in people with Hepatitis C Virus Infection, Response to Therapy of, run by Egyptian Liver Hospital at 1 site in Egypt.
Trial summary
Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Hepatitis C Virus Infection, Response to Therapy of
- What is being tested?
- 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) and 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)
- 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
- 15 Apr 2017to 31 May 2019
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Willing and able to provide written informed consent.
- 12-18 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
- Screening ECG without clinically significant abnormalities.
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- Patients must have the following laboratory parameters at screening:
- ALT (Alanine transaminase) ≤ 10 x the upper limit of normal (ULN)
- AST (Aspartate Aminotransferase) ≤ 10 x ULN
- Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female patients
- Platelets > 50,000 cells/mm3
- INR (international normalized ratio) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
- Albumin ≥ 3 g/dL
- HbA1c ≤ 10%
- Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
- Patient has not been treated with any investigational drug or device within 30 days of the screening visit.
Who cannot join
- 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).
- 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.
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- History of significant pulmonary disease, significant cardiac disease or porphyria.
- 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 the study investigational medicinal product, the metabolites, or formulation excipients.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)
- Being tested
- 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg), 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)Drug
Also called Normal track
Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks
8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)Drug
Also called Short track
Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 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. Receives: Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) |
| Arm 2 | Active comparator | Treatment-experienced is defined as:
1. IFN Intolerant
2. Non-response
3. Relapse/Breakthrough Receives: Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) |
| Short Track | Experimental | Treatment-naïve or Treatment-experienced who achived very rapid virological responce - Negative HCV PCR after treatment with (Sofosbuvir 400mg/Ledipasvir 90mg) for 1 week Receives: Drug: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
sustained viral response 12 weeks after discontinuation of therapy (SVR12)
Measured: 12 weeks after discontinuation of therapy
Secondary outcomes (1)
SVR4
sustained viral response 4 weeks after discontinuation of therapy (SVR4)
Measured: 4 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.
- First posted17 Nov 2017
- Study start15 Apr 2017
- Primary completion1 Nov 2018 (estimated)
- Study completion31 May 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 Virus Infection, Response to Therapy ofStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egyptian Liver Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gamal Shiha, MD, Principal investigator, Egyptian Liver Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343444
- Sponsor's protocol ID
- PED-ELH-2017
- Status last verified
- May 2018
- First submitted
- 27 Mar 2017
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents
- ClinicalTrials.gov ID
- NCT03343444
- Acronym / sponsor ID
- PED-ELH-2017
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Egyptian Liver HospitalUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 17 Nov 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.
Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)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. |
| Arm 2 | Active comparator | Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)Treatment-experienced is defined as: 1. IFN Intolerant 2. Non-response 3. Relapse/Breakthrough |
| Short Track | Experimental | Drug: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)Treatment-naïve or Treatment-experienced who achived very rapid virological responce - Negative HCV PCR after treatment with (Sofosbuvir 400mg/Ledipasvir 90mg) for 1 week |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Willing and able to provide written informed consent.
- 12-18 years
- HCV RNA ≥ 104 IU/mL at screening.
- Confirmed chronic HCV infection as documented by either:
- Screening ECG without clinically significant abnormalities.
Key exclusion criteria (10 listed)
- 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).
- 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.
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 |
|---|---|---|
| 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)Also: Normal trackSingle Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks | Drug | Arm 1, Arm 2 |
| 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)Also: Short trackSingle Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks | Drug | Short Track |
Primary outcome
SVR12
Time frame: 12 weeks after discontinuation of therapy
sustained viral response 12 weeks after discontinuation of therapy (SVR12)
1 secondary outcome
SVR4
Time frame: 4 weeks after discontinuation of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: No
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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.
Gamal Shiha, MD principal investigator
Egyptian Liver Hospital
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 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) and 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) in people with Hepatitis C Virus Infection, Response to Therapy of, 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 16 inclusion and 10 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 24 May 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 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?
Results are not available in the source record.
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?
SVR12 (time frame: 12 weeks after discontinuation of therapy). 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 24 May 2018.