Hepatitis C VirusNCT04038320

Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine

An observational study of Hepatitis C Virus, run by Right to Care at 2 sites in Ukraine.

Completed

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

Trial summary

The project will evaluate cost and treatment outcomes of a simplified Hepatitis C Virus (HCV) testing, treatment and care model integrated with HIV testing and treatment among key affected populations in Ukraine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Virus
What is being tested?: Sofosbuvir/ledipasvir (SOF/LDV)
Type of treatment: Pill or oral medicine
How many people: 868 participants
Where: 2 sitesUkraine
Study dates: 26 Mar 2018to 30 Jun 2019
Phase: Observational
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

Study population: The study population are HCV treatment naïve or experienced (pegylated interferon [PegIFN] and ribavirin [RBV] only), HCV-infected with genotype 1, 2, 3, 4, 5 or 6, men and women aged 18 years or older, with or without HIV-1 co-infection, representatives of key populations (PWID, CSW, MSM) and their partners. Participants with compensated cirrhosis or Hepatitis B will be eligible for HCV treatment. Patients with decompensated liver cirrhosis or prior treatment with HCV DAAs will not be eligible for treatment. HCV-infected patients who are not eligible for HCV treatment will be eligible for an observation arm.

Who may be able to join

Ability and willingness of participant to provide informed consent.
Attribution to one of the key population groups: People Who Inject Drugs (PWID), medication assisted treatment (MAT) participants, Commercial Sex Workers (CSW) or Men Having Sex with Men (MSM). Documentation of attribution to one of the key population groups will be done through applying Case Reporting Form "Risks Assessment" and "Substance Use and Alcohol Consumption". Additionally, medical record of substance use can be collected
Men and women age 18 years.
Active HCV infection as defined by detectable serum or plasma HCV RNA at any time prior to study entry. Documentation may be obtained from medical records if available. If no medical records on HCV infection are available, HCV infection must be confirmed by a detectable HCV RNA PCR prior to project entry.
Allowed HCV treatment history:
HCV treatment naïve defined as not having been previously treated for Hepatitis C infection with any medications approved for the treatment of HCV in any country.

Show all 23Show fewer

HCV treatment experienced with interferon with or without ribavirin only (no prior DAA treatment, although they will be followed).
Hepatitis B status must be documented by hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and hepatitis B core antibody (HBcAb) testing. Participants with positive hepatitis B surface antigen (HBsAg+) must be on an active HBV regimen at study entry.
HIV-1 infection status must be documented as either absent or present, as defined below:
Absence of HIV-1 infection, as documented by rapid HIV test or HIV-1 enzyme immunoassay (ELISA) test kit, within 60 days prior to entry.
OR
Presence of HIV-1 infection, documented by rapid HIV test or HIV-1 ELISA test kit at any time prior to entry and confirmed by a second antibody test by a method other than the initial rapid HIV and/or ELISA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.
OR
HIV-1 infection confirmed by medical documentation as participant is registered in care at AIDS Center and receiving or preparing to initiate ARV treatment.
Participants who are assigned to receive ribavirin as part of the treatment protocol must have haemoglobin ≥110 g/L
For females of reproductive potential, a negative urine pregnancy test (urine -HCG with a sensitivity of <25 mIU/mL) within 48 hours prior to project entry must be documented.
Male and female participants who are able to impregnate or become pregnant (ie, of reproductive potential) and are participating in sexual activity that could lead to pregnancy must agree to practice contraception/birth control as indicated below or agree to not participate in a conception process while on treatment with ribavirin through at least 12 weeks post-treatment.
Note: Acceptable contraception/birth control for this project includes one of the following methods:
condoms (male or female) with a spermicide
diaphragm or cervical cap with spermicide
hormonally impregnated intrauterine device (IUD)
non-hormonally impregnated IUD in conjunction with spermicide
Hormone-based therapy

Who cannot join

Child-Pugh Score corresponding to Class B or C (decompensated cirrhosis). This requires assessment for encephalopathy and ascites, as well as measurement of serum bilirubin, albumin, and international normalized ratio (Prothrombin time). For Child's cirrhosis severity calculator on the following link can be used: http://www.hepatitisc.uw.edu/page/clinical-calculators/ctp . Patients with decompensated cirrhosis and advanced liver disease will not be included to the treatment program, but they will remain under observation and will receive medical care within routine medical practice of the healthcare facility in such clinical cases.
Breastfeeding or pregnancy. Pregnant or breastfeeding woman will be documented and provided access to HCV treatment after resolution of pregnancy and breastfeeding.
Known allergy/sensitivity or any hypersensitivity to components of drug(s) or their formulation.
Active tuberculosis (TB) infection. Given the high TB prevalence in Ukraine, every candidate should be screened for TB signs/symptoms with further medical evaluation for active TB as indicated. In the case of proven active TB infection, the participant is ineligible for HCV treatment (due to the adverse drug interaction of SOF/LDV and rifampicin) but will be followed and offered enrolment when they complete treatment with rifampicin.
Renal impairment defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or end-stage renal disease receiving dialysis as treatment with SOF/LDV is contraindicated (https://www.mdcalc.com/mdrd-gfr-equation). The participant may be rescreened if the renal function improves. Patients with worse renal impairment will not be treated but will be followed and will recive medical aid within routine medical practice of the healthcare facility where project is implemented
Prior treatment with any HCV Direct Acting Agents (DAA).

Trial locations and contacts

2 sites in 1 country.

Ukraine2 sites

Clinic of the Institute of Epidemiology and Infectious Diseases, National Academy of Medical Sciences of Ukraine
Kiev
Kyiv City Clinical Hospital #5
Kyiv

Other trials in Ukraine

About this study

Official title: Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine

Read the detailed description

Affected populations will be screened for HCV and HIV and those HCV positive treated with direct with direct acting anti-HCV agents (DAAs), a fixed-dose combination of sofosbuvir/ledipasvir (SOF/LDV) for 12 weeks with or without weight-based ribavirin. Before and after completion of the treatment course viral load assessments will be undertaken using low-cost laboratory monitoring for comparison to standard HCV viral load measurement. Up 800 patients enrolled on treatment will be followed up at 4, 8, 12 and 24 weeks when Sustained Viral Response (SVR) will be determined. Safety monitoring will be undertaken at applicable visits for those on Ribavirin and all adverse events will be reported based on Good Clinical Practice (GCP). In addition to assessing cost outcomes, the project will assess HCV treatment efficacy in terms of SVR at 12 weeks after end of treatment ( defined as undetected HCV RNA or less than lower limit of detection), compare the cost of low cost viral assay platforms to standard of care, assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV treatment model and impact of HIV co-infection in participants on the HCV treatment outcome of SVR12. The project will be conducted at 2 treatment sites in Kiev.

Conditions: Hepatitis C Virus
Being tested: Sofosbuvir/ledipasvir (SOF/LDV)
Keywords: Hepatitis C Virus, HIV, Key Population
Medical subject headings: Hepatitis C

What participants receive

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

Sofosbuvir/ledipasvir (SOF/LDV)Drug
SOF/LDV (400mg/90mg) orally once daily with or without food in the morning and will receive treatment for a duration of 12 weeks.
In addition, Ribavirin weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food for Genotype 3 patients.

Study groups in NCT04038320
Study group	Role	What they receive
HCV infected patients		All HCV infected confirmed by HCV RNA, Receives: Drug: Sofosbuvir/ledipasvir (SOF/LDV)

What is being measured

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

Estimated cost of HCV screening per patient screened and per case identified and the cost per successfully treated patient for HCV mono-infected and co-infected participants
The average cost to the provider per patient achieving SVR-12 will be estimated, as will the average cost per other outcomes achieved, such as per patient screened and per patient remaining in care by other specified endpoints, stratified by HIV status and by any other important patient or site characteristics that are identified as drivers of cost. The investigators will also estimate the average cost to "produce" a successful outcome (SVR-12), which is the ratio of total costs for the intervention for the entire sample enrolled to the number of patients achieving the primary outcome. This latter estimate captures the costs incurred for patients who do not have successful outcomes and thus relates resource utilization to health outcomes.
Measured: Two years. This will be after data on Viral load response is complete.
Sustained Viral Response
This will be the main treatment outcome of all patients initiated on treatment. Baseline viral load is done at entry with treatment initiated for those positive and eligible. Patients initiated on treatment will be assessed for viral load response at 24 weeks ( 12 weeks post treatment). This will also help in development of a Care cascade model for HCV testing, treatment and SVR12 in key populations co-infected with HIV/HCV, HIV/HCV/HBV, HBV/HCV and HCV mono-infected.
Measured: 24 weeks ( 12 weeks post treatment)

Secondary outcomes (5)

HCV genotype
HCV genotype will be determined at entry for all patients.
Measured: At baseline
HCV subtype
All genotypes will be subtyped once
Measured: Baseline
Validity of Cepheid Gene-Xpert in monitoring SVR12
150 patients will be evaluated for HCV viral load at entry and exit comparing Cepheid Gen-Xpert and Real time PCR using Ampliscence platform.
Measured: Testing done and baseline and 24 weeks
HIV viral load among HCV/HIV co-infected patients
HCV/HIV co-infected patients will be on treatment at the time of HCV treatment initiation but those not on ART will be initiated and will assess rates of ART initiation and virologic suppression of the HIV infected within the simplified HCV testing and treatment model
Measured: HIV Viral load at 24 weeks ( 12 weeks post HCV treatment)
Reliability of Cepheid Gene-Xpert in monitoring SVR12
Cepheid Gen-Xpert and Real time PCR using Ampliscence platform.
Measured: Testing done and baseline and 24 weeks

Timeline

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

26 Mar 201830 Jun 2019

First posted30 Jul 2019
Study start26 Mar 2018
Primary completion30 Mar 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Hepatitis C VirusStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 868 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04038320
Sponsor's protocol ID: EQUIPHCV02-UKR
Status last verified: Jun 2018
First submitted: 4 Jul 2018
Last updated: 30 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014 Nov;61(1 Suppl):S45-57. doi: 10.1016/j.jhep.2014.07.027. Epub 2014 Jul 30.
PubMed 25086286
Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.
PubMed 23172780
Jaenisch T, Junghanss T, Wills B, Brady OJ, Eckerle I, Farlow A, Hay SI, McCall PJ, Messina JP, Ofula V, Sall AA, Sakuntabhai A, Velayudhan R, Wint GR, Zeller H, Margolis HS, Sankoh O; Dengue in Africa Study Group. Dengue expansion in Africa-not recognized or not happening? Emerg Infect Dis. 2014 Oct;20(10):e140487. doi: 10.3201/eid2010.140487.
PubMed 25271370
Lazarus JV, Sperle I, Maticic M, Wiessing L. A systematic review of Hepatitis C virus treatment uptake among people who inject drugs in the European Region. BMC Infect Dis. 2014;14 Suppl 6(Suppl 6):S16. doi: 10.1186/1471-2334-14-S6-S16. Epub 2014 Sep 19.
PubMed 25252742
Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.
PubMed 26571066
Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015 Nov;149(6):1454-1461.e1. doi: 10.1053/j.gastro.2015.07.063. Epub 2015 Aug 7.
PubMed 26261007

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?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine
ClinicalTrials.gov ID: NCT04038320
Acronym / sponsor ID: EQUIPHCV02-UKR
Conditions: Hepatitis C Virus
Keywords: Hepatitis C Virus, HIV, Key Population
Study type: Observational
Recruitment status: Completed
Enrolment: 868 participants (actual)
Lead sponsor: Right to CareUniversity, hospital or other
Collaborators: All Ukrainian Network of PLHA, Public Health Center of MOH Ukraine, Alliance for the Public's Health, Boston University, University of California, Los Angeles
Study start: 26 Mar 2018 (actual)
Primary completion: 30 Mar 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 30 Jul 2019 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
HCV infected patients	–	Drug: Sofosbuvir/ledipasvir (SOF/LDV)All HCV infected confirmed by HCV RNA,

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population are HCV treatment naïve or experienced (pegylated interferon [PegIFN] and ribavirin [RBV] only), HCV-infected with genotype 1, 2, 3, 4, 5 or 6, men and women aged 18 years or older, with or without HIV-1 co-infection, representatives of key populations (PWID, CSW, MSM) and their partners. Participants with compensated cirrhosis or Hepatitis B will be eligible for HCV treatment. Patients with decompensated liver cirrhosis or prior treatment with HCV DAAs will not be eligible for treatment. HCV-infected patients who are not eligible for HCV treatment will be eligible for an observation arm.

Key inclusion criteria (23 listed)

Ability and willingness of participant to provide informed consent.
Attribution to one of the key population groups: People Who Inject Drugs (PWID), medication assisted treatment (MAT) participants, Commercial Sex Workers (CSW) or Men Having Sex with Men (MSM). Documentation of attribution to one of the key population groups will be done through applying Case Reporting Form "Risks Assessment" and "Substance Use and Alcohol Consumption". Additionally, medical record of substance use can be collected
Men and women age 18 years.
Active HCV infection as defined by detectable serum or plasma HCV RNA at any time prior to study entry. Documentation may be obtained from medical records if available. If no medical records on HCV infection are available, HCV infection must be confirmed by a detectable HCV RNA PCR prior to project entry.
Allowed HCV treatment history:

Key exclusion criteria (6 listed)

Child-Pugh Score corresponding to Class B or C (decompensated cirrhosis). This requires assessment for encephalopathy and ascites, as well as measurement of serum bilirubin, albumin, and international normalized ratio (Prothrombin time). For Child's cirrhosis severity calculator on the following link can be used: http://www.hepatitisc.uw.edu/page/clinical-calculators/ctp . Patients with decompensated cirrhosis and advanced liver disease will not be included to the treatment program, but they will remain under observation and will receive medical care within routine medical practice of the healthcare facility in such clinical cases.
Breastfeeding or pregnancy. Pregnant or breastfeeding woman will be documented and provided access to HCV treatment after resolution of pregnancy and breastfeeding.
Known allergy/sensitivity or any hypersensitivity to components of drug(s) or their formulation.
Active tuberculosis (TB) infection. Given the high TB prevalence in Ukraine, every candidate should be screened for TB signs/symptoms with further medical evaluation for active TB as indicated. In the case of proven active TB infection, the participant is ineligible for HCV treatment (due to the adverse drug interaction of SOF/LDV and rifampicin) but will be followed and offered enrolment when they complete treatment with rifampicin.
Renal impairment defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or end-stage renal disease receiving dialysis as treatment with SOF/LDV is contraindicated (https://www.mdcalc.com/mdrd-gfr-equation). The participant may be rescreened if the renal function improves. Patients with worse renal impairment will not be treated but will be followed and will recive medical aid within routine medical practice of the healthcare facility where project is implemented

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/ledipasvir (SOF/LDV)SOF/LDV (400mg/90mg) orally once daily with or without food in the morning and will receive treatment for a duration of 12 weeks. In addition, Ribavirin weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food for Genotype 3 patients.	Drug	HCV infected patients

Primary outcome

Estimated cost of HCV screening per patient screened and per case identified and the cost per successfully treated patient for HCV mono-infected and co-infected participants
Time frame: Two years. This will be after data on Viral load response is complete.
The average cost to the provider per patient achieving SVR-12 will be estimated, as will the average cost per other outcomes achieved, such as per patient screened and per patient remaining in care by other specified endpoints, stratified by HIV status and by any other important patient or site characteristics that are identified as drivers of cost. The investigators will also estimate the average cost to "produce" a successful outcome (SVR-12), which is the ratio of total costs for the intervention for the entire sample enrolled to the number of patients achieving the primary outcome. This latter estimate captures the costs incurred for patients who do not have successful outcomes and thus relates resource utilization to health outcomes.
Sustained Viral Response
Time frame: 24 weeks ( 12 weeks post treatment)
This will be the main treatment outcome of all patients initiated on treatment. Baseline viral load is done at entry with treatment initiated for those positive and eligible. Patients initiated on treatment will be assessed for viral load response at 24 weeks ( 12 weeks post treatment). This will also help in development of a Care cascade model for HCV testing, treatment and SVR12 in key populations co-infected with HIV/HCV, HIV/HCV/HBV, HBV/HCV and HCV mono-infected.

5 secondary outcomes

HCV genotype
Time frame: At baseline
HCV subtype
Time frame: Baseline
Validity of Cepheid Gene-Xpert in monitoring SVR12
Time frame: Testing done and baseline and 24 weeks
HIV viral load among HCV/HIV co-infected patients
Time frame: HIV Viral load at 24 weeks ( 12 weeks post HCV treatment)
Reliability of Cepheid Gene-Xpert in monitoring SVR12
Time frame: Testing done and baseline and 24 weeks

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Results publication: PubMed 25086286Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014 Nov;61(1 Suppl):S45-57. doi: 10.1016/j.jhep.2014.07.027. Epub 2014 Jul 30.
Results publication: PubMed 23172780Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.
Results publication: PubMed 25271370Jaenisch T, Junghanss T, Wills B, Brady OJ, Eckerle I, Farlow A, Hay SI, McCall PJ, Messina JP, Ofula V, Sall AA, Sakuntabhai A, Velayudhan R, Wint GR, Zeller H, Margolis HS, Sankoh O; Dengue in Africa Study Group. Dengue expansion in Africa-not recognized or not happening? Emerg Infect Dis. 2014 Oct;20(10):e140487. doi: 10.3201/eid2010.140487.
Results publication: PubMed 25252742Lazarus JV, Sperle I, Maticic M, Wiessing L. A systematic review of Hepatitis C virus treatment uptake among people who inject drugs in the European Region. BMC Infect Dis. 2014;14 Suppl 6(Suppl 6):S16. doi: 10.1186/1471-2334-14-S6-S16. Epub 2014 Sep 19.
Results publication: PubMed 26571066Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.
Results publication: PubMed 26261007Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015 Nov;149(6):1454-1461.e1. doi: 10.1053/j.gastro.2015.07.063. Epub 2015 Aug 7.
Over 5% of Ukrainians are infected with hepatitis C. 2016Link provided by the sponsor.
EASL Recommendations on Treatment of Hepatitis C 2016. 2016Link provided by the sponsor.
Individual participant dataSharing planned: Yes

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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.

Ian Sanne, MBBCH, FRCP study chair

Right to Care

Svetlana Antonyak, MD principal investigator

Hepatitis and HIV-infection of Institute of Epidemiology and Infectious Diseases of L.V. Gromashevskiy of NAMS of Ukraine

Tetiana Benard, MA principal investigator

Right to Care, Ukraine

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

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Virus, run by Right to Care at 2 sites in Ukraine.

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 23 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ukraine. 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?

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?

Estimated cost of HCV screening per patient screened and per case identified and the cost per successfully treated patient for HCV mono-infected and co-infected participants (time frame: Two years. This will be after data on Viral load response is complete.). 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 NCT04038320, which also lists 6 linked publications.

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 30 Jul 2019.