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Chronic Hepatitis CPhase 4SHAREDNCT02964091

Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

A Phase 4 study testing sofosbuvir/ledipasvir in people with Chronic Hepatitis C, run by Partners in Health at 1 site in Rwanda.

Completed

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

Official record
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Trial summary

The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
sofosbuvir/ledipasvir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteRwanda
Study dates
Oct 2016to 28 Aug 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients that are willing and able to provide written informed consent
  • age ≥ 18 years
  • HCV RNA ≥ 103 IU/mL
  • HCV genotype 1 or 4
  • screening ultrasound excluding hepatocellular carcinoma (HCC)
  • acceptable laboratory values (hemoglobin ≥8.0 g/dL, platelet count ≥40,000/mm3; AST, ALT, and alkaline phosphatase ≤10 × ULN; creatinine clearance ≥30 mL/min)
Show all 9Show fewer
  • general good health
  • ability to comply with study procedures
  • HIV-infected patients must have completed at least 6 months of any approved HIV antiretroviral therapy (ART) per Rwanda National Guidelines 2013, have been taking for at least 2 weeks prior to screening ART compatible with SOF/LDV (efavirenz, rilpivirine, raltegravir, dolutegravir, emtricitabine, lamivudine, zidovudine, tenofovir), have screening HIV RNA < 200 copies/mL, and have screening CD4 T-cell count of ≥100 cells/µL

Who cannot join

  • current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
  • active tuberculosis
  • other clinically-significant illness (except HCV and/or HIV) or any other major medical disorder
  • active Hepatitis B infection
  • difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
  • any IFN-containing regimen within 8 weeks prior to screening or any prior exposure to HCV-specific direct-acting antiviral agent (other than a NS3/4A protease inhibitor and SOF), current pregnancy or breastfeeding, and active drug or alcohol use or dependence

Trial locations and contacts

1 site in 1 country.

Rwanda1 site

  • Rwanda Military Hospital

    Kanombe, Kigali, 00000

Other trials in Rwanda

About this study

The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.

Read the detailed description

This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in HCV treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 HCV infection. Approximately 240 participants will be enrolled and treated with sofosbuvir (SOF) 400 mg/LDV 90 mg fixed dose combination (FDC) one tablet once daily for 12 weeks in the SHARED 1 study. Sixty additional participants will be enrolled in the SHARED 2 sub-cohort with laboratory monitoring blinded to study clinicians.

Being tested
sofosbuvir/ledipasvir
Keywords
Hepatitis C Virus, sofosbuvir/ledipasvir, Efficacy
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

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

  • sofosbuvir/ledipasvirDrug

    Also called Harvoni

Study groups in NCT02964091
Study groupRoleWhat they receive
HarvoniOthersofosbuvir/ledipasvir once daily for 12 weeks
Receives: Drug: sofosbuvir/ledipasvir

What is being measured

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

  1. Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment

    To determine the hepatitis C virus (HCV) antiviral efficacy of sofosbuvir/ledipasvir (SOF/LDV) fixed-dose combination (FDC) as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12) in Rwanda.

    Measured: After study completion (24 weeks)

  2. Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment, with limited lab monitoring

    To determine the HCV antiviral efficacy of SOF/LDV FDC, as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12), with limited lab monitoring in Rwanda.

    Measured: After study completion (24 weeks)

  3. Proportion of participants with a new grade 3 or 4 adverse event or premature study drug discontinuation due to an adverse event.

    To evaluate the safety and tolerability of SOF/LDV FDC in Rwanda

    Measured: After study completion (24 weeks)

Secondary outcomes (9)

  1. A set of minimum required monitoring tests

    A set of minimum required monitoring tests

    Measured: After study completion (24 weeks)

  2. Distribution of HCV genotypes subtypes among participants

    Distribution of HCV genotypes subtypes among participants

    Measured: After study completion (24 weeks)

  3. SVR12, stratified by genotypic subtype

    SVR12, stratified by genotypic subtype

    Measured: After study completion (24 weeks)

  4. Basic demographic and clinical characteristics of patients referred for HCV treatment

    Basic demographic and clinical characteristics of patients referred for HCV treatment

    Measured: After study completion (24 weeks)

  5. Adherence to SOF/LDV measured by pill count

    Adherence to SOF/LDV measured by pill count

    Measured: After 12 weeks medication therapy

  6. Proportion of participants with virologic failure

    Proportion of participants with virologic failure

    Measured: After study completion (24 weeks)

  7. Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment

    Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment

    Measured: After study completion (24 weeks)

  8. Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment

    Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment

    Measured: After 12 weeks of medication therapy

  9. Proportion of participants reporting increased quality of life after SVR12 using the Medical Outcomes Study HIV Health Survey

    To determine the effect of SOF/LDV and SVR12 on quality of life in Rwanda

    Measured: After study completion (24 weeks)

Timeline

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

  1. First posted15 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion28 Aug 2020
  4. Study completion28 Aug 2020

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964091
Sponsor's protocol ID
SHARED 092415
Acronym
SHARED
Status last verified
Sep 2021
First submitted
3 Nov 2016
Last updated
21 Sep 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The study protocol, study data, data dictionary, data collection instruments, and informed consent forms are available upon request from the corresponding author. De-identifiable individual participant data will be made available 9 months after the publication date and ending 36 months after the publication date. Forms and data can be accessed by written request to the corresponding author and the study sponsor, Partners In Health. The data will be made available following evaluation and approval of proposed use by the study sponsor and signed data access agreement with the study sponsor.

Publications

  • Gupta N, Mbituyumuremyi A, Kabahizi J, Ntaganda F, Muvunyi CM, Shumbusho F, Musabeyezu E, Mukabatsinda C, Ntirenganya C, Van Nuil JI, Kateera F, Camus G, Damascene MJ, Nsanzimana S, Mukherjee J, Grant PM. Treatment of chronic hepatitis C virus infection in Rwanda with ledipasvir-sofosbuvir (SHARED): a single-arm trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):119-126. doi: 10.1016/S2468-1253(18)30382-0. Epub 2018 Dec 11.

    PubMed 30552056

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sofosbuvir/ledipasvir in people with Chronic Hepatitis C, run by Partners in Health at 1 site in Rwanda.

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 6 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 21 Sep 2021. 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 Rwanda. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment (time frame: After study completion (24 weeks)). The study lists 3 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 NCT02964091, 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 21 Sep 2021.

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