Chronic Hepatitis C InfectionPhase 2/3DASCONCT02555943
DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)
A Phase 2/3 study testing Ledipasvir/Sofosbuvir, Sofosbuvir and Daclatasvir and Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir in people with Chronic Hepatitis C Infection and HBV Coinfection, run by Humanity and Health Research Centre at 1 site in China.
Trial summary
This is a prospective study to determine the incidence, morbidity, mortality and predisposing factors for the reactivation of hepatitis B virus replication during direct anti-HCV treatment of HCV/HBV co-infection patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Infection, HBV Coinfection, Hepatitis B Reactivation
- What is being tested?
- Ledipasvir/Sofosbuvir, Sofosbuvir and Daclatasvir and Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Aug 2021
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV RNA positive,
- HBsAg positive with detectable or undetectable HBV DNA,
- Receiving pan oral direct-acting anti-HCV regimen
Who cannot join
- Pregnant or nursing female or male with pregnant female partner;
- HIV infection;
- Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
- Active or recent history (≤ 1 year) of drug or alcohol abuse;
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients
This is a prospective study to determine the incidence, morbidity, mortality and predisposing factors for the reactivation of hepatitis B virus replication during direct anti-HCV treatment of HCV/HBV co-infection patients.
Read the detailed description
Patients who receive direct-acting anti-HCV treatment will be prospectively studied during 2-year period. All patients have HCV/HBV co-infection.
The inclusion/exclusion criteria and the follow up plan will be listed in following part.
- Being tested
- Ledipasvir/Sofosbuvir, Sofosbuvir and Daclatasvir, Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, Entecavir, Tenofovir disoproxil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ledipasvir/SofosbuvirDrug
Also called Harvoni®, GS-7977, GS-5885
Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
Sofosbuvir and DaclatasvirDrug
Also called Sovaldi®, GS-7977, Daklinza®,BMS-790052
TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.
Ombitasvir, Paritaprevir, Ritonavir, DasabuvirDrug
Also called VIEKIRA PAK™
VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.
EntecavirDrug
Also called BARACLUDE®
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
Tenofovir disoproxilDrug
Also called VIREAD®
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic/Early anti-HBV treatment | Active comparator | HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection before or at the commencement of direct anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
. Receives: Drug: Ledipasvir/Sofosbuvir; Drug: Sofosbuvir and Daclatasvir; Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; Drug: Entecavir; Drug: Tenofovir disoproxil |
| Deferred anti-HBV treatment | Experimental | HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection when HBV viral breakthrough occurred during anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin). Receives: Drug: Ledipasvir/Sofosbuvir; Drug: Sofosbuvir and Daclatasvir; Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; Drug: Entecavir; Drug: Tenofovir disoproxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who experience virological breakthrough
Virological breakthrough is defined as 1 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.
Measured: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Proportion of participants who experience virological rebound
Virological rebound is defined as 2 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.
Measured: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Secondary outcomes (1)
Proportion of participant who experience biochemical rebound
Biochemical rebound is defined as
Measured: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C InfectionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanity and Health Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, Nanfang Hospital, Southern Medical University
- Responsible party
- Principal investigator, George Lau, Humanity and Health Research Centre
- Investigators
- George Lau, M.D., Principal investigator, Humanity and Health GI and Liver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555943
- Sponsor's protocol ID
- H&H_DASCO
- Acronym
- DASCO
- Status last verified
- Aug 2021
- First submitted
- 20 Sep 2015
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients
- ClinicalTrials.gov ID
- NCT02555943
- Acronym / sponsor ID
- DASCO / H&H_DASCO
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, Nanfang Hospital, Southern Medical University
- Study start
- Feb 2015 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 22 Sep 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.
This is a prospective study to determine the incidence, morbidity, mortality and predisposing factors for the reactivation of hepatitis B virus replication during direct anti-HCV treatment of HCV/HBV co-infection patients.
Detailed description
Patients who receive direct-acting anti-HCV treatment will be prospectively studied during 2-year period. All patients have HCV/HBV co-infection.
The inclusion/exclusion criteria and the follow up plan will be listed in following part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic/Early anti-HBV treatment | Active comparator | Drug: Ledipasvir/Sofosbuvir, Drug: Sofosbuvir and Daclatasvir, Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, Drug: Entecavir, Drug: Tenofovir disoproxilHCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection before or at the commencement of direct anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin). . |
| Deferred anti-HBV treatment | Experimental | Drug: Ledipasvir/Sofosbuvir, Drug: Sofosbuvir and Daclatasvir, Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, Drug: Entecavir, Drug: Tenofovir disoproxilHCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection when HBV viral breakthrough occurred during anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HCV RNA positive,
- HBsAg positive with detectable or undetectable HBV DNA,
- Receiving pan oral direct-acting anti-HCV regimen
Key exclusion criteria (5 listed)
- Pregnant or nursing female or male with pregnant female partner;
- HIV infection;
- Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
- Active or recent history (≤ 1 year) of drug or alcohol abuse;
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
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 |
|---|---|---|
| Ledipasvir/SofosbuvirAlso: Harvoni®, GS-7977, GS-5885Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily. | Drug | Deferred anti-HBV treatment, Prophylactic/Early anti-HBV treatment |
| Sofosbuvir and DaclatasvirAlso: Sovaldi®, GS-7977, Daklinza®,BMS-790052TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily. | Drug | Deferred anti-HBV treatment, Prophylactic/Early anti-HBV treatment |
| Ombitasvir, Paritaprevir, Ritonavir, DasabuvirAlso: VIEKIRA PAK™VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor. | Drug | Deferred anti-HBV treatment, Prophylactic/Early anti-HBV treatment |
| EntecavirAlso: BARACLUDE®Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. | Drug | Deferred anti-HBV treatment, Prophylactic/Early anti-HBV treatment |
| Tenofovir disoproxilAlso: VIREAD®VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. | Drug | Deferred anti-HBV treatment, Prophylactic/Early anti-HBV treatment |
Primary outcome
Proportion of participants who experience virological breakthrough
Time frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Virological breakthrough is defined as 1 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.
Proportion of participants who experience virological rebound
Time frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Virological rebound is defined as 2 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.
1 secondary outcome
Proportion of participant who experience biochemical rebound
Time frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
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 1 Sep 2021.
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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.
George Lau, M.D. principal investigator
Humanity and Health GI and Liver Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ledipasvir/Sofosbuvir, Sofosbuvir and Daclatasvir and Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir in people with Chronic Hepatitis C Infection and HBV Coinfection, run by Humanity and Health Research Centre at 1 site in China.
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 3 inclusion and 5 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 1 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 China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 who experience virological breakthrough (time frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment). 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?
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 1 Sep 2021.