Chronic Hepatitis cNCT03481036
DAA Therapy in Pediatric Patients With Chronic Hepatitis C
A study testing Direct Acting Antivirals, DAAs in Cirrhotics Genotype 2/3 and DAAs in Cirrhotics Genotye 1,4,5,6 in people with Chronic Hepatitis c, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Chronic Hepatitis c
- What is being tested?
- Direct Acting Antivirals, DAAs in Cirrhotics Genotype 2/3 and DAAs in Cirrhotics Genotye 1,4,5,6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 18 Jun 2016to 31 Dec 2020
- Phase
- Interventional
- 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
- Chronic hepatitis C, all genotypes
- Ages eligible for study: ≥12 to <18 years (Child)
- Gender eligible for study: either
- Treatment-naive or treatment-experienced: either
Who cannot join
- Chronic liver disease of a non-HCV etiology
- serum creatinine >1.5 mg/dL
- Evidence of hepatocellular carcinoma or other malignancy
- Co-infection with hepatitis B virus, or HIV
- Significant cardiovascular, pulmonary, or neurological disease
- Evidence of a malabsorption syndrome that could interfere with absorption of orally administered medications
- History of solid organ or bone marrow transplantation.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
Radha K Dhiman, DM, 911722756335, rkpsdhiman@hotmail.com
About this study
Official title: Direct Acting Antiviral Agent (DAA) Therapy Is Safe and Efficacious in Pediatric Patients With Chronic Hepatitis C: Real World Data From the Public Health Perspective
The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed
Read the detailed description
Consecutive chronic hepatitis C (HCV) infected children [age: ≥12 to <18 years; both treatment-naïve (TN) and treatment-experienced, (TE)] are being enrolled.
Genotyping is not recommended for non-cirrhotic or TN patients and are treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis and TE patients.
Patients with liver cirrhosis or TE and genotype (GT)-3 are being treated with SOF+DCV for 24 weeks,
while non-GT-3 patients are being treated with SOF+LDV for 24-weeks. Patients < 35 kg are being given half doses of medications and patients ≥35 kg are being given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day.
- Conditions
- Chronic Hepatitis c
- Being tested
- Direct Acting Antivirals, DAAs in Cirrhotics Genotype 2/3, DAAs in Cirrhotics Genotye 1,4,5,6
- Keywords
- Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF, Direct acting antiviral agents (DAA), Chronic Hepatitis C, Pediatric population, Adolescent Chronic Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Acting AntiviralsDrug
Also called DAAs in Non Cirrhotics
Sofosbuvir and Daclatasvir
DAAs in Cirrhotics Genotype 2/3Drug
Sofosbuvir and Daclatasvir with weight based ribavirin
DAAs in Cirrhotics Genotye 1,4,5,6Drug
Sofosbuvir and Ledipasvir with weight based ribavirin
| Study group | Role | What they receive |
|---|---|---|
| Non cirrhotic | Active comparator | Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day Receives: Drug: Direct Acting Antivirals |
| Genotype 1,4,5 and 6 with cirrhosis | Active comparator | Sofosbuvir (SOF)+ Ledipasvir (LDV) for 12-weeks + weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and LDV (90 mg) per day Receives: Drug: DAAs in Cirrhotics Genotye 1,4,5,6 |
| Genotype 2 and 3 with Cirrhosis | Active comparator | Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks+ weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and DCV (60 mg) per day Receives: Drug: DAAs in Cirrhotics Genotype 2/3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virological Response (SVR 12)
HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)
Measured: 12 weeks after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start18 Jun 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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 Chronic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Directorate of Health and Family Welfare, Punjab
- Responsible party
- Principal investigator, Radha K Dhiman, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481036
- Sponsor's protocol ID
- IEC/2018/000323
- Status last verified
- Jun 2019
- First submitted
- 22 Mar 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhiman RK, Grover GS, Premkumar M, Taneja S, Duseja A, Rathi S, Satsangi S. Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):74-80. doi: 10.1097/MPG.0000000000002139.
PubMed 30211847
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Acting Antiviral Agent (DAA) Therapy Is Safe and Efficacious in Pediatric Patients With Chronic Hepatitis C: Real World Data From the Public Health Perspective
- ClinicalTrials.gov ID
- NCT03481036
- Acronym / sponsor ID
- IEC/2018/000323
- Conditions
- Chronic Hepatitis c
- Keywords
- Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF, Direct acting antiviral agents (DAA), Chronic Hepatitis C, Pediatric population, Adolescent Chronic Hepatitis C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Directorate of Health and Family Welfare, Punjab
- Study start
- 18 Jun 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Mar 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.
The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed
Detailed description
Consecutive chronic hepatitis C (HCV) infected children [age: ≥12 to <18 years; both treatment-naïve (TN) and treatment-experienced, (TE)] are being enrolled.
Genotyping is not recommended for non-cirrhotic or TN patients and are treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis and TE patients.
Patients with liver cirrhosis or TE and genotype (GT)-3 are being treated with SOF+DCV for 24 weeks,
while non-GT-3 patients are being treated with SOF+LDV for 24-weeks. Patients < 35 kg are being given half doses of medications and patients ≥35 kg are being given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non cirrhotic | Active comparator | Drug: Direct Acting AntiviralsSofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day |
| Genotype 1,4,5 and 6 with cirrhosis | Active comparator | Drug: DAAs in Cirrhotics Genotye 1,4,5,6Sofosbuvir (SOF)+ Ledipasvir (LDV) for 12-weeks + weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and LDV (90 mg) per day |
| Genotype 2 and 3 with Cirrhosis | Active comparator | Drug: DAAs in Cirrhotics Genotype 2/3Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks+ weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and DCV (60 mg) per day |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Chronic hepatitis C, all genotypes
- Ages eligible for study: ≥12 to <18 years (Child)
- Gender eligible for study: either
- Treatment-naive or treatment-experienced: either
Key exclusion criteria (7 listed)
- Chronic liver disease of a non-HCV etiology
- serum creatinine >1.5 mg/dL
- Evidence of hepatocellular carcinoma or other malignancy
- Co-infection with hepatitis B virus, or HIV
- Significant cardiovascular, pulmonary, or neurological disease
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 |
|---|---|---|
| Direct Acting AntiviralsAlso: DAAs in Non CirrhoticsSofosbuvir and Daclatasvir | Drug | Non cirrhotic |
| DAAs in Cirrhotics Genotype 2/3Sofosbuvir and Daclatasvir with weight based ribavirin | Drug | Genotype 2 and 3 with Cirrhosis |
| DAAs in Cirrhotics Genotye 1,4,5,6Sofosbuvir and Ledipasvir with weight based ribavirin | Drug | Genotype 1,4,5 and 6 with cirrhosis |
Primary outcome
Sustained Virological Response (SVR 12)
Time frame: 12 weeks after completion of therapy
HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Derived from this study: PubMed 30211847Dhiman RK, Grover GS, Premkumar M, Taneja S, Duseja A, Rathi S, Satsangi S. Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):74-80. doi: 10.1097/MPG.0000000000002139.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Acting Antivirals, DAAs in Cirrhotics Genotype 2/3 and DAAs in Cirrhotics Genotye 1,4,5,6 in people with Chronic Hepatitis c, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 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 17 Jun 2019. 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 India. 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.
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 Radha K Dhiman, DM (911722756335, rkpsdhiman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virological Response (SVR 12) (time frame: 12 weeks after completion of therapy). 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 NCT03481036, 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 17 Jun 2019.