Hepatitis C, ChronicPhase 4D3FEATNCT02498015
A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection
A Phase 4 study testing "3D" regimen and "3D" regimen with ribavirin in people with Hepatitis C, Chronic, run by Kirby Institute at 1 site in Australia.
Trial summary
A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with genotype 1a infection or cirrhosis will receive 12 weeks of open-label paritaprevir/ritonavir/ombitasvir and dasabuvir ("3D"), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- "3D" regimen and "3D" regimen with ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2016to Mar 2019
- 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
- Detectable HCV RNA in plasma (>1,000 IU/ml).
- Evidence of positive HCV antibody >6 months prior to screening.
- HCV Genotype 1 infection.
- Recent IDU (previous 6 months) or receiving stable OST (stable dose for >2 weeks).
- Never received treatment for HCV infection.
- Compensated liver disease. Enrolment of patients with cirrhosis (FibroScan >14.6 kPa or FIB-4 > 3.25) will be capped to 60% of the total enrolment (maximum 3 per site).
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- Participants with FibroScan > 12KPa or AFP >50 ng/mL must have abdominal ultrasound or CT scan without evidence of hepatocellular carcinoma within 2 months before screening.
- Negative pregnancy test (for women of childbearing potential) within the 24-hour period before the first dose of study drug.
- All fertile participants must be using effective contraception during treatment and 24 weeks post treatment (patients treated with ribavirin) or 2 weeks post treatment (patients not treated with ribavirin).
Who cannot join
- Any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months before the first dose of study drug.
- Any investigational drug ≤6 weeks before the first dose of study drug.
- HIV infection.
- History or other evidence of decompensated liver disease.
- Neutrophil <1000 cells/mm3 or platelet <50,000 cells/mm3 at screening.
- Serum creatinine >1.5 x upper limit of normal at screening.
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- Ongoing severe psychiatric disease as judged by the treating physician.
- Frequent IDU that is judged by the treating physician to compromise treatment safety.
- Hemoglobin <12 g/dL (<7.4 mmol/L) in women or <13 g/dL (<8.1 mmol/L) in men at screening.
- Any exclusion specific to paritaprevir/ritonavir/ombitasvir, dasabuvir or ribavirin.
- Pregnancy/lactation or male subjects whose female partners are pregnant.
- Subject has current or past clinical evidence of decompensated liver disease, such as ascites, hepatic encephalopathy, oesophageal varices, and/or any of the following screening laboratory results;
- International normalised ration (INR) >1.5; i. Patients with a known inherited blood disorder and INR > 1.5 may be enrolled after discussion with the Principal Investigator b. Serum albumin <3.3 g/dL; c. Serum total bilirubin >1.8 x ULN, unless isolated in subjects with Gilbert's syndrome.
- Subject shows evidence of significant liver disease in addition to HCV, which may include but is not limited to drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis (NASH), or primary biliary cirrhosis.
- Subject has active malignant disease or history of malignant disease within the past 5 years (except treated basal cell carcinoma).
- History of chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
- Poorly controlled diabetes mellitus as evidenced by haemoglobin A1c (HbA1c) ≥8.5%.
- Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab or HBsAg.
- Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or on an ultrasound performed at screening (a positive ultrasound result will be confirmed with CT scan or MRI).
- Subject has history of organ transplant that requires chronic immunosuppression.
- Corneal, skin, and hair grafts are allowed.
- History of severe psychiatric disease that in the opinion of the investigator is unstable enough to compromise treatment adherence.
- Prohibited medications and herbal remedies as detailed in the study protocol.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Kirby Institute, University of New South Wales Australia
Sydney, New South Wales, 2052
About this study
Official title: A Phase IV Open-label, Multicentre, International Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir ±Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection and Recent Injection Drug Use or Receiving Opioid Substitution Therapy
A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with genotype 1a infection or cirrhosis will receive 12 weeks of open-label paritaprevir/ritonavir/ombitasvir and dasabuvir ("3D"), and twice-daily ribavirin. Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label "3D". The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and follow-up phase (96 weeks) to evaluate treatment response and reinfection.
Read the detailed description
A total of 100 people with recent injection drug use or recipients of opioid substitution therapy will be enrolled from drug and alcohol clinics, tertiary liver and infectious diseases clinics and community health centres across Canada, Europe, New Zealand, France, and Australia. This will include at least 30 participants with F3/F4 liver disease. Participants will be considered recent injection drug users if they have used injection drugs in the 6 months prior to consent. Participants receiving stable opioid substitution therapy (stable dose for >2 weeks) will also be included. Patients with frequent drug use that is judged by the treating physician to compromise treatment safety will be excluded. The study drugs consisting of two tablets of the co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, one dasabuvir tablet (250 mg) twice daily, ribavirin (1000 mg) daily in two divided doses (genotype 1a only and/or cirrhosis). Electronic blister packs will be used to improve and monitor treatment adherence. This innovative strategy with the "3D" interferon-free regimen could considerably enhance the capacity to scale-up HCV treatment among PWID, and is therefore being evaluated in this phase IV study within a well-defined PWID population.
- Conditions
- Hepatitis C, Chronic
- Being tested
- "3D" regimen, "3D" regimen with ribavirin
- 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.
"3D" regimenDrug
Also called Viekira pack
The "3D" regimen contain paritaprevir/ritonavir/ombitasvir (75/50/12.5mg) once daily, dasabuvir 250mg twice daily for genotype 1b without cirrhosis.
"3D" regimen with ribavirinDrug
Also called Viekira pack with ribavirin
The "3D" regimen with ribavirin contain paritaprevir/ritonavir/ombitasvir (75/50/12.5mg) once daily, dasabuvir 250mg twice daily, and ribavirin (1000 mg regardless of weight) daily in two divided doses for genotype 1a and genotype 1b with cirrhosis.
| Study group | Role | What they receive |
|---|---|---|
| "3D" regimen | Experimental | The "3D" regimen contain two tablets of co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, and one dasabuvir tablet (250 mg) twice daily for genotype 1b without cirrhosis. Treatment will be 12 weeks. Receives: Drug: "3D" regimen |
| "3D" regimen with ribavirin | Experimental | The "3D" regimen with ribavirin contain two tablets of co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, one dasabuvir tablet (250 mg) twice daily, and ribavirin (1000 mg regardless of weight) daily in two divided doses for genotype 1a (with/without) and genotype 1b with cirrhosis. Treatment will be for 12 weeks. Receives: Drug: "3D" regimen with ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12)
To evaluate the proportion of participants with undetectable HCV RNA 12 weeks post end of treatment (SVR12) following the "3D" regimen with or without ribavirin for 12 weeks in people with chronic HCV genotype 1 infection.
Measured: 12 weeks post treatment
Secondary outcomes (15)
The proportion of participants with undetectable HCV RNA at 2 weeks following the initiation of treatment - week 2
To evaluate the proportion of participants with undetectable HCV RNA after receiving 2 weeks of "3D" regimen with or without ribavirin.
Measured: 2 weeks following the initiation of treatment
The proportion of participants with undetectable HCV RNA at 4 weeks following the initiation of treatment - week 4
To evaluate the proportion of participants with undetectable HCV RNA after receiving 4 weeks of "3D" regimen with or without ribavirin.
Measured: 4 weeks following the initiation of treatment
The proportion of participants with undetectable HCV RNA at the end of treatment - week 12
To evaluate the proportion of participants with undetectable HCV RNA at the end of treatment after receiving 12 weeks of "3D" regimen with or without ribavirin.
Measured: End of treatment week 12
The proportion of participants with undetectable HCV RNA at 24 weeks post end of treatment (SVR24)
To evaluate the proportion of participants with undetectable HCV RNA 24 weeks (SVR24) post end of treatment.
Measured: 24 weeks post treatment
Treatment adherence
To evaluate the proportion of participants adherent to treatment (both on-treatment adherence and treatment discontinuation).
Measured: Baseline to week 12
Association between adherence and response to treatment
To evaluate the association between adherence and response to treatment [including an evaluation of the impact of early (0-3 weeks), mid (4-7 weeks) and late (8-11 weeks) missed doses on response to treatment]; adherence will be measured via a self report questionnaire and pill count via return of the weekly blister packs. The impact of the number and timing of the missed pills will be evaluated.
Measured: Early (0-3 weeks), mid (4-7 weeks), late (8-11 weeks) during treatment
Safety and tolerability (number and type of adverse events and serious adverse events)
To evaluate the number and type of adverse events and serious adverse
Measured: Baseline to week 24 (SVR24)
Change in injecting drug use and injecting risk behaviour
To evaluate the change in injecting drug use and injecting risk behaviours during and following treatment. Change in injecting drug use and injecting risk behaviour will be measured via a self report behavioural questionnaire completed by participants at baseline, week 4 during treatment, week 8 during treatment and end of treatment.
Measured: Baseline to week 12
Change in mental health
To evaluate the change in mental health during treatment. Change in mental health will be measured by self report mental health questionnaire (Kessler10) at baseline, week 4 during treatment and end of treatment.
Measured: Baseline to week 12
Change in health-related quality of life Questionnaire
To evaluate the change in health-related quality of life during treatment. Change in health-related quality of life will be measured by self report questionnaire (EQ-5D) at baseline, week 4 during treatment and end of treatment.
Measured: Baseline to week 12
Impact of mixed HCV infection on treatment response
To evaluate the rate of mixed HCV infection at baseline and among those with treatment non-response
Measured: Baseline to SVR12
Change in opioid substitution therapy
To evaluate the change in OST during treatment (dose and any discontinuation)
Measured: Baseline to week 12
HCV reinfection rate
To evaluate the rate of HCV reinfection during and following treatment
Measured: Week 108
Emergence of viral resistance-associated variants (RAVs)
To evaluate the emergence of viral resistance-associated variants (RAVs). HCV sequencing will be performed on the baseline EDTA plasma samples of all participants at baseline to detect any baseline RAVs and will be preformed on the EDTA plasma samples of the participants who experienced virological failure to detect the emergence of RAVs.
Measured: Baseline to week 12
Utility of HCV core antigen testing as a simple method for HCV monitoring
To evaluate the utility of HCV core antigen testing as a simple method for HCV monitoring including treatment response. HCV RNA will be measured using the HCV core antigen test and then compared to HCV RNA levels measured using standard methods (EDTA plasma samples and Roche TaqMan).
Measured: Week 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gregory Dore, MBBS, PhD, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498015
- Sponsor's protocol ID
- VHCRP1405
- Acronym
- D3FEAT
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2015
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cunningham EB, Hajarizadeh B, Amin J, Hellard M, Bruneau J, Feld JJ, Cooper C, Powis J, Litwin AH, Marks P, Dalgard O, Conway B, Moriggia A, Stedman C, Read P, Bruggmann P, Lacombe K, Dunlop A, Applegate TL, Matthews GV, Fraser C, Dore GJ, Grebely J. Reinfection Following Successful Direct-acting Antiviral Therapy for Hepatitis C Virus Infection Among People Who Inject Drugs. Clin Infect Dis. 2021 Apr 26;72(8):1392-1400. doi: 10.1093/cid/ciaa253.
PubMed 32166305Artenie AA, Cunningham EB, Dore GJ, Conway B, Dalgard O, Powis J, Bruggmann P, Hellard M, Cooper C, Read P, Feld JJ, Hajarizadeh B, Amin J, Lacombe K, Stedman C, Litwin AH, Marks P, Matthews GV, Quiene S, Erratt A, Bruneau J, Grebely J. Patterns of Drug and Alcohol Use and Injection Equipment Sharing Among People With Recent Injecting Drug Use or Receiving Opioid Agonist Treatment During and Following Hepatitis C Virus Treatment With Direct-acting Antiviral Therapies: An International Study. Clin Infect Dis. 2020 May 23;70(11):2369-2376. doi: 10.1093/cid/ciz633.
PubMed 31300820
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Open-label, Multicentre, International Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir ±Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection and Recent Injection Drug Use or Receiving Opioid Substitution Therapy
- ClinicalTrials.gov ID
- NCT02498015
- Acronym / sponsor ID
- D3FEAT / VHCRP1405
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 15 Jul 2015 (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.
A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with genotype 1a infection or cirrhosis will receive 12 weeks of open-label paritaprevir/ritonavir/ombitasvir and dasabuvir ("3D"), and twice-daily ribavirin. Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label "3D". The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and follow-up phase (96 weeks) to evaluate treatment response and reinfection.
Detailed description
A total of 100 people with recent injection drug use or recipients of opioid substitution therapy will be enrolled from drug and alcohol clinics, tertiary liver and infectious diseases clinics and community health centres across Canada, Europe, New Zealand, France, and Australia. This will include at least 30 participants with F3/F4 liver disease. Participants will be considered recent injection drug users if they have used injection drugs in the 6 months prior to consent. Participants receiving stable opioid substitution therapy (stable dose for >2 weeks) will also be included. Patients with frequent drug use that is judged by the treating physician to compromise treatment safety will be excluded. The study drugs consisting of two tablets of the co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, one dasabuvir tablet (250 mg) twice daily, ribavirin (1000 mg) daily in two divided doses (genotype 1a only and/or cirrhosis). Electronic blister packs will be used to improve and monitor treatment adherence. This innovative strategy with the "3D" interferon-free regimen could considerably enhance the capacity to scale-up HCV treatment among PWID, and is therefore being evaluated in this phase IV study within a well-defined PWID population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "3D" regimen | Experimental | Drug: "3D" regimenThe "3D" regimen contain two tablets of co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, and one dasabuvir tablet (250 mg) twice daily for genotype 1b without cirrhosis. Treatment will be 12 weeks. |
| "3D" regimen with ribavirin | Experimental | Drug: "3D" regimen with ribavirinThe "3D" regimen with ribavirin contain two tablets of co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, one dasabuvir tablet (250 mg) twice daily, and ribavirin (1000 mg regardless of weight) daily in two divided doses for genotype 1a (with/without) and genotype 1b with cirrhosis. Treatment will be for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Detectable HCV RNA in plasma (>1,000 IU/ml).
- Evidence of positive HCV antibody >6 months prior to screening.
- HCV Genotype 1 infection.
- Recent IDU (previous 6 months) or receiving stable OST (stable dose for >2 weeks).
- Never received treatment for HCV infection.
Key exclusion criteria (23 listed)
- Any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months before the first dose of study drug.
- Any investigational drug ≤6 weeks before the first dose of study drug.
- HIV infection.
- History or other evidence of decompensated liver disease.
- Neutrophil <1000 cells/mm3 or platelet <50,000 cells/mm3 at screening.
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 |
|---|---|---|
| "3D" regimenAlso: Viekira packThe "3D" regimen contain paritaprevir/ritonavir/ombitasvir (75/50/12.5mg) once daily, dasabuvir 250mg twice daily for genotype 1b without cirrhosis. | Drug | "3D" regimen |
| "3D" regimen with ribavirinAlso: Viekira pack with ribavirinThe "3D" regimen with ribavirin contain paritaprevir/ritonavir/ombitasvir (75/50/12.5mg) once daily, dasabuvir 250mg twice daily, and ribavirin (1000 mg regardless of weight) daily in two divided doses for genotype 1a and genotype 1b with cirrhosis. | Drug | "3D" regimen with ribavirin |
Primary outcome
The proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12)
Time frame: 12 weeks post treatment
To evaluate the proportion of participants with undetectable HCV RNA 12 weeks post end of treatment (SVR12) following the "3D" regimen with or without ribavirin for 12 weeks in people with chronic HCV genotype 1 infection.
15 secondary outcomes
The proportion of participants with undetectable HCV RNA at 2 weeks following the initiation of treatment - week 2
Time frame: 2 weeks following the initiation of treatment
The proportion of participants with undetectable HCV RNA at 4 weeks following the initiation of treatment - week 4
Time frame: 4 weeks following the initiation of treatment
The proportion of participants with undetectable HCV RNA at the end of treatment - week 12
Time frame: End of treatment week 12
The proportion of participants with undetectable HCV RNA at 24 weeks post end of treatment (SVR24)
Time frame: 24 weeks post treatment
Treatment adherence
Time frame: Baseline to week 12
Association between adherence and response to treatment
Time frame: Early (0-3 weeks), mid (4-7 weeks), late (8-11 weeks) during treatment
Safety and tolerability (number and type of adverse events and serious adverse events)
Time frame: Baseline to week 24 (SVR24)
Change in injecting drug use and injecting risk behaviour
Time frame: Baseline to week 12
Change in mental health
Time frame: Baseline to week 12
Change in health-related quality of life Questionnaire
Time frame: Baseline to week 12
Impact of mixed HCV infection on treatment response
Time frame: Baseline to SVR12
Change in opioid substitution therapy
Time frame: Baseline to week 12
HCV reinfection rate
Time frame: Week 108
Emergence of viral resistance-associated variants (RAVs)
Time frame: Baseline to week 12
Utility of HCV core antigen testing as a simple method for HCV monitoring
Time frame: Week 108
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 13 Jun 2019.
- Derived from this study: PubMed 32166305Cunningham EB, Hajarizadeh B, Amin J, Hellard M, Bruneau J, Feld JJ, Cooper C, Powis J, Litwin AH, Marks P, Dalgard O, Conway B, Moriggia A, Stedman C, Read P, Bruggmann P, Lacombe K, Dunlop A, Applegate TL, Matthews GV, Fraser C, Dore GJ, Grebely J. Reinfection Following Successful Direct-acting Antiviral Therapy for Hepatitis C Virus Infection Among People Who Inject Drugs. Clin Infect Dis. 2021 Apr 26;72(8):1392-1400. doi: 10.1093/cid/ciaa253.
- Derived from this study: PubMed 31300820Artenie AA, Cunningham EB, Dore GJ, Conway B, Dalgard O, Powis J, Bruggmann P, Hellard M, Cooper C, Read P, Feld JJ, Hajarizadeh B, Amin J, Lacombe K, Stedman C, Litwin AH, Marks P, Matthews GV, Quiene S, Erratt A, Bruneau J, Grebely J. Patterns of Drug and Alcohol Use and Injection Equipment Sharing Among People With Recent Injecting Drug Use or Receiving Opioid Agonist Treatment During and Following Hepatitis C Virus Treatment With Direct-acting Antiviral Therapies: An International Study. Clin Infect Dis. 2020 May 23;70(11):2369-2376. doi: 10.1093/cid/ciz633.
- 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.
Gregory Dore, MBBS, PhD principal investigator
Kirby Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "3D" regimen and "3D" regimen with ribavirin in people with Hepatitis C, Chronic, run by Kirby Institute at 1 site in Australia.
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 23 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 13 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 Australia. 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?
The proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) (time frame: 12 weeks post treatment). 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 NCT02498015, which also lists 2 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 13 Jun 2019.