Hepatitis cNCT02762448
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas
An observational study of Hepatitis c, run by Tainan Municipal Hospital.
Trial summary
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis c
- What is being tested?
- Daclatasvir+ Asunaprevir
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 18 Apr 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an open label pilot without control group or other intervention. Participants will be recruited to a known intervention. Assessments will be conducted in an unblinded fashion. In terms of genotypes, 1b and 2a were suggested to be risk factors for the developing lymphoma in most HCV patients. In HCV-infected patients with splenic marginal zone or indolent B-cell NHL, many studies reported that combined treatment with interferon-alpha and ribavirin may lead to HCV clearance and concomitant regression of lymphomas
Who may be able to join
- Men and women
- 18 to 70 years of age
- Who had chronic HCV genotype 1b infection
- An HCV RNA level of 105 IU per milliliter or higher
- Being diagnosed to be low grade B cell non-Hodgkin lymphoma
Who cannot join
- Patients with hepatitis B virus infection,
- Other liver diseases
- HIV infection,
- Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N
- Evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results.
About this study
Official title: Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study
Read the detailed description
Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks The patients will be observed and followed to determine whether there is regression of NHL after antiviral treatment. Conventional chemotherapy should be initiated shortly in cases without regression.
- Conditions
- Hepatitis c
- Being tested
- Daclatasvir+ Asunaprevir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daclatasvir+ AsunaprevirDrug
Also called DCV;ASV
HCV clearance and complete regression of NHL by ASV+ DCV
| Study group | Role | What they receive |
|---|---|---|
| Daclatasvir + Asunaprevir | Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks . Receives: Drug: Daclatasvir+ Asunaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV clearance and complete regression of NHL by ASV+ DCV
patients who had undetectable HCV RNA levels at or after week 4. Viral relapse was defined as confirmed detectable HCV RNA levels during the post-treatment follow-up period in patients who had had undetectable HCV RNA levels at the end of treatment
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2018 (estimated)
- Study completion18 Apr 2018
Why it stopped: no patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis cStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tainan Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762448
- Sponsor's protocol ID
- AI447-122
- Status last verified
- Apr 2018
- First submitted
- 28 Apr 2016
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study
- ClinicalTrials.gov ID
- NCT02762448
- Acronym / sponsor ID
- AI447-122
- Conditions
- Hepatitis c
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tainan Municipal HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 5 May 2016 (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.
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study
Detailed description
Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks The patients will be observed and followed to determine whether there is regression of NHL after antiviral treatment. Conventional chemotherapy should be initiated shortly in cases without regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daclatasvir + Asunaprevir | – | Drug: Daclatasvir+ AsunaprevirProspectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an open label pilot without control group or other intervention. Participants will be recruited to a known intervention. Assessments will be conducted in an unblinded fashion. In terms of genotypes, 1b and 2a were suggested to be risk factors for the developing lymphoma in most HCV patients. In HCV-infected patients with splenic marginal zone or indolent B-cell NHL, many studies reported that combined treatment with interferon-alpha and ribavirin may lead to HCV clearance and concomitant regression of lymphomas
Key inclusion criteria (5 listed)
- Men and women
- 18 to 70 years of age
- Who had chronic HCV genotype 1b infection
- An HCV RNA level of 105 IU per milliliter or higher
- Being diagnosed to be low grade B cell non-Hodgkin lymphoma
Key exclusion criteria (5 listed)
- Patients with hepatitis B virus infection,
- Other liver diseases
- HIV infection,
- Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N
- Evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results.
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 |
|---|---|---|
| Daclatasvir+ AsunaprevirAlso: DCV;ASVHCV clearance and complete regression of NHL by ASV+ DCV | Drug | Daclatasvir + Asunaprevir |
Primary outcome
HCV clearance and complete regression of NHL by ASV+ DCV
Time frame: 2years
patients who had undetectable HCV RNA levels at or after week 4. Viral relapse was defined as confirmed detectable HCV RNA levels during the post-treatment follow-up period in patients who had had undetectable HCV RNA levels at the end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis c, run by Tainan Municipal Hospital.
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 5 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: withdrawn, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
HCV clearance and complete regression of NHL by ASV+ DCV (time frame: 2years). 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 19 Apr 2018.