Pharmacological ActionPhase 2/3NCT02985281
Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients
A Phase 2/3 study testing Sofosbuvir Oral Product and Ribavirin in people with Pharmacological Action, run by National Liver Institute, Egypt at 1 site in Egypt.
Trial summary
Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Sofosbuvir Oral Product and Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Sep 2017
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis C virus.
- willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent.
- Patient with child,s Pugh class B or C, compensated cirrhosis may be enrolled.
Who cannot join
- Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml.
- Patient with coinfection of hepatitis B virus or Human Immunodeficiency Virus will be excluded.
- Creatinine clearance < 50 ml/minute.
- Albumin<3 gm/dl.
- aspartate aminotransferase or alanine aminotransferase > 10 upper limit of normal.
- Pregnant and lactating females.
- Associated morbidity such as uncontrolled diabetes mellitus, schistosomiasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Daul Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection. A Prospective, Randomized, Multicenter Study
Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.
Read the detailed description
Male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis C virus, willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent. Patient with childs Pugh class B or C, compensated cirrhosis may be enrolled. Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml and patient with coinfection of Hepatitis B virus or HIV will be excluded. Participation in the study procedures is anticipated to last up to 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.
A detailed treatment log of the returned investigational product will be established with the investigator (or the pharmacist) and countersigned by the investigator and the monitoring team.
Compliance is assessed by counting the number of returned tablets at each visit.
A discontinuation is defined as a period with at least seven consecutive days without study drug intake.
Safety and efficacy will be compared between cirrhotic versus non-cirrhotic subjects in multivariate model to test the impact of this pretreatment characteristic on safety, tolerability and efficacy endpoints.
Safety analysis:clinical adverse events will be displayed by body system (soc) for each study subject and by treatment group, using MedDRA coding. Summary of statistics of safety and efficacy endpoints will be displayed by stratification parameters.
- Conditions
- Pharmacological Action
- Being tested
- Sofosbuvir Oral Product, Ribavirin
- Keywords
- direct acting antiviral drugs, chronic hepatitis C virus infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir Oral ProductDrug
Also called Gratisovir
direct acting antiviral drug for HCV infection
RibavirinDrug
antiviral drug for HCV infection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 20 patients will be randomly assigned into arm 1; treated for fixed 24 duration with Gratisovir (Sofosbuvir) and Ribavirin. First intervention 'Sofosbuvir oral product' 200 mg tablet with food on daily doses based on body weight (20-29.9 kg will take one 200 mg tab daily); (30-39.9 kg will take 1.5 tab 200 mg daily); (> 40 kg will take 2 tab 200 mg daily).
Second intervention 'Ribavirin oral product' 200 mg tab on (15 mg/kg daily) doses based on body weight. Receives: Drug: Sofosbuvir Oral Product; Drug: Ribavirin |
| Arm 2 | Active comparator | 20 patients will be randomly assigned into arm 2; treated as response guided duration; patient who show very rapid virological (undetectable HCV RNA after 2 weeks) will be treated for 16 weeks duration and reset will complete the 24 weeks duration.
Intervention 'Sofosbuvir Oral Product' 200 mg tablet with food on daily doses based on body weight (20-29.9 kg will take one 200 mg tab daily); (30-39.9 kg will take 1.5 tab 200 mg daily); (> 40 kg will take 2 tab 200 mg daily).
Second intervention 'Ribavirin oral product' 200 mg tab on (15 mg/kg daily) doses based on body weight. Receives: Drug: Sofosbuvir Oral Product; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SVR12 in both treatment groups after 12 following completion of treatment (SVR12)
incidence of SVR12 in both treatment groups after 12 weeks following completion of treatment (SVR12)
Measured: 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.
Secondary outcomes (1)
assessment of the nature, severity and frequency of the adverse effects and absolute values and changes over time from pre-dose values for hematology clinical chemistry, urine analysis, vital signs and ECG parameters.
Safety and tolerability are assessed by: the nature, severity and frequency of the adverse effects and absolute values and changes over time from pre-dose values for hematology clinical chemistry, urine analysis, vital signs and ECG parameters. Clinical adverse events will be displayed by body system (SOC) for each study subject and by treatment group, using MedDRA coding. Absolute laboratory values, changes and its graded abnormalities will be displayed) for each study subject and by treatment group. The proportions of subjects experiencing Clinical adverse events and laboratory abnormalities of a given type will be computed and presented along with descriptive statistics. Vital signs data will be similarly assessed, and any post baseline changes in physical examination findings will be summarized in tubular form, by subject and by treatment cohort.
Summary statistics of efficacy and safety end points will be displayed by stratification parameters
Measured: 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Liver Institute, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Pharco Pharmaceuticals
- Responsible party
- Principal investigator, Samira Abdel-Wahab Abdel- Aziz, National Liver Institute, Egypt
- Investigators
- Behairy Behairy, professor, Study director, National Liver Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985281
- Sponsor's protocol ID
- 00114/2016
- Status last verified
- Dec 2016
- First submitted
- 21 Nov 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Daul Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection. A Prospective, Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT02985281
- Acronym / sponsor ID
- 00114/2016
- Conditions
- Pharmacological Action
- Keywords
- direct acting antiviral drugs, chronic hepatitis C virus infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- National Liver Institute, EgyptUniversity, hospital or other
- Collaborators
- Pharco Pharmaceuticals
- Study start
- Dec 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 7 Dec 2016 (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.
Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.
Detailed description
Male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis C virus, willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent. Patient with childs Pugh class B or C, compensated cirrhosis may be enrolled. Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml and patient with coinfection of Hepatitis B virus or HIV will be excluded. Participation in the study procedures is anticipated to last up to 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.
A detailed treatment log of the returned investigational product will be established with the investigator (or the pharmacist) and countersigned by the investigator and the monitoring team.
Compliance is assessed by counting the number of returned tablets at each visit.
A discontinuation is defined as a period with at least seven consecutive days without study drug intake.
Safety and efficacy will be compared between cirrhotic versus non-cirrhotic subjects in multivariate model to test the impact of this pretreatment characteristic on safety, tolerability and efficacy endpoints.
Safety analysis:clinical adverse events will be displayed by body system (soc) for each study subject and by treatment group, using MedDRA coding. Summary of statistics of safety and efficacy endpoints will be displayed by stratification parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Sofosbuvir Oral Product, Drug: Ribavirin20 patients will be randomly assigned into arm 1; treated for fixed 24 duration with Gratisovir (Sofosbuvir) and Ribavirin. First intervention 'Sofosbuvir oral product' 200 mg tablet with food on daily doses based on body weight (20-29.9 kg will take one 200 mg tab daily); (30-39.9 kg will take 1.5 tab 200 mg daily); (> 40 kg will take 2 tab 200 mg daily). Second intervention 'Ribavirin oral product' 200 mg tab on (15 mg/kg daily) doses based on body weight. |
| Arm 2 | Active comparator | Drug: Sofosbuvir Oral Product, Drug: Ribavirin20 patients will be randomly assigned into arm 2; treated as response guided duration; patient who show very rapid virological (undetectable HCV RNA after 2 weeks) will be treated for 16 weeks duration and reset will complete the 24 weeks duration. Intervention 'Sofosbuvir Oral Product' 200 mg tablet with food on daily doses based on body weight (20-29.9 kg will take one 200 mg tab daily); (30-39.9 kg will take 1.5 tab 200 mg daily); (> 40 kg will take 2 tab 200 mg daily). Second intervention 'Ribavirin oral product' 200 mg tab on (15 mg/kg daily) doses based on body weight. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis C virus.
- willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent.
- Patient with child,s Pugh class B or C, compensated cirrhosis may be enrolled.
Key exclusion criteria (7 listed)
- Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml.
- Patient with coinfection of hepatitis B virus or Human Immunodeficiency Virus will be excluded.
- Creatinine clearance < 50 ml/minute.
- Albumin<3 gm/dl.
- aspartate aminotransferase or alanine aminotransferase > 10 upper limit of normal.
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 |
|---|---|---|
| Sofosbuvir Oral ProductAlso: Gratisovirdirect acting antiviral drug for HCV infection | Drug | Arm 1, Arm 2 |
| Ribavirinantiviral drug for HCV infection | Drug | Arm 1, Arm 2 |
Primary outcome
Incidence of SVR12 in both treatment groups after 12 following completion of treatment (SVR12)
Time frame: 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.
incidence of SVR12 in both treatment groups after 12 weeks following completion of treatment (SVR12)
1 secondary outcome
assessment of the nature, severity and frequency of the adverse effects and absolute values and changes over time from pre-dose values for hematology clinical chemistry, urine analysis, vital signs and ECG parameters.
Time frame: 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- 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.
Behairy Behairy, professor study director
National Liver Institute, Egypt
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 Sofosbuvir Oral Product and Ribavirin in people with Pharmacological Action, run by National Liver Institute, Egypt 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 7 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 19 Dec 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?
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?
Incidence of SVR12 in both treatment groups after 12 following completion of treatment (SVR12) (time frame: 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.). 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 19 Dec 2016.