Hepatitis C Virus InfectionPhase 2NCT02868242

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy

A Phase 2 study testing LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer chemotherapy. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Hepatitis C Virus Infection
What is being tested?: LDV/SOF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteEgypt
Study dates: 28 Aug 2016to 3 Feb 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Aged 12 to <18 years
Parent or legal guardian must provide written informed consent
Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen
Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy
Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
Screening laboratory values within defined thresholds

Show all 9Show fewer

No History of solid organ or bone marrow transplantation
No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

National Cancer Institute, Cairo University
Cairo

Other trials in Egypt

About this study

Official title: A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Undergoing Cancer Chemotherapy

Conditions: Hepatitis C Virus Infection
Being tested: LDV/SOF
Keywords: HCV genotype 1 or 4 (GT-1 or GT-4), Direct Acting Antiviral, Combination Therapy, Hepatitis C, Chronic, Liver Diseases, Virus Diseases
Medical subject headings: Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LDV/SOFDrug
Also called Harvoni®, GS-5885/GS-7977
Tablet(s) administered orally once daily

Study groups in NCT02868242
Study group	Role	What they receive
LDV/SOF	Experimental	Participants will receive LDV/SOF 90/400 mg fixed dose combination (FDC) (1x 90/400 mg tablet or 4 x 22.5/100 mg tablets based on swallowability assessment during screening) for 12 weeks. Receives: Drug: LDV/SOF

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Measured: First dose date up to Week 12

Secondary outcomes (5)

Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Measured: Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Measured: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Measured: Weeks 1, 4, 8, and 12
HCV RNA Change From Baseline/Day 1
Measured: Baseline; Weeks 1, 4, 8, and 12
Percentage of Participants With Virologic Failure
Virologic failure was defined as:
- On-treatment virologic failure:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
- Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
- Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
Measured: Baseline to Posttreatment Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20163 Feb 2019

First posted16 Aug 2016 (estimated)
Study start28 Aug 2016
Primary completion12 Nov 2018
Study completion3 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02868242
Sponsor's protocol ID: GS-US-337-1904
Status last verified: Jul 2019
First submitted: 11 Aug 2016
Last updated: 2 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Publications

El-Sayed MH, Ebeid FSE, Zekri AR, Massetto B, Kersey K, Zhang F, Gaggar A, Elsayed W, El-Haddad A. Ledipasvir-sofosbuvir in Adolescents With Chronic Hepatitis C and Hematological Malignancies Undergoing Chemotherapy. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):626-630. doi: 10.1097/MPG.0000000000003406. Epub 2022 Feb 10.
PubMed 35149641

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Undergoing Cancer Chemotherapy
ClinicalTrials.gov ID: NCT02868242
Acronym / sponsor ID: GS-US-337-1904
Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 1 or 4 (GT-1 or GT-4), Direct Acting Antiviral, Combination Therapy, Hepatitis C, Chronic, Liver Diseases, Virus Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 28 Aug 2016 (actual)
Primary completion: 12 Nov 2018 (actual)
Study completion: 3 Feb 2019 (actual)
First posted: 16 Aug 2016 (estimated)
Results: Posted 20 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LDV/SOF	Experimental	Drug: LDV/SOFParticipants will receive LDV/SOF 90/400 mg fixed dose combination (FDC) (1x 90/400 mg tablet or 4 x 22.5/100 mg tablets based on swallowability assessment during screening) for 12 weeks.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

Aged 12 to <18 years
Parent or legal guardian must provide written informed consent
Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen
Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy
Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy

Key exclusion criteria (0 listed)

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
LDV/SOFAlso: Harvoni®, GS-5885/GS-7977Tablet(s) administered orally once daily	Drug	LDV/SOF

Primary outcome

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time frame: First dose date up to Week 12

5 secondary outcomes

Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
Time frame: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Time frame: Weeks 1, 4, 8, and 12
HCV RNA Change From Baseline/Day 1
Time frame: Baseline; Weeks 1, 4, 8, and 12
Percentage of Participants With Virologic Failure
Time frame: Baseline to Posttreatment Week 24

Results and safety

Results posted to the registry on 20 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LDV/SOF	19	19

Primary outcome: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Time frame: Posttreatment Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	LDV/SOF n = 19
Value	100.0 (82.4 to 100.0)

Population analysed: Full Analysis Set included participants who took at least 1 dose of study drug.

Primary outcome: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

Time frame: First dose date up to Week 12. Number. Unit: percentage of participants

Measure	LDV/SOF n = 19
Value	0

Population analysed: Safety Analysis Set included participants who took at least 1 dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LDV/SOF	3 of 19 (15.8%)	15 of 19 (78.9%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35149641El-Sayed MH, Ebeid FSE, Zekri AR, Massetto B, Kersey K, Zhang F, Gaggar A, Elsayed W, El-Haddad A. Ledipasvir-sofosbuvir in Adolescents With Chronic Hepatitis C and Hematological Malignancies Undergoing Chemotherapy. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):626-630. doi: 10.1097/MPG.0000000000003406. Epub 2022 Feb 10.
Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Related trials for Hepatitis C Virus Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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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.

Gilead Study Director study director

Gilead Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences 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 9 inclusion and 0 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: finished, as of the sponsor's last update on 2 Mar 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment Week 12). 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?

On the ClinicalTrials.gov record for NCT02868242, 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 2 Mar 2020.