Hepatitis C, ChronicPhase 4NCT02624063
Randomized Clinical Trial of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus Genotype 1 (TNT)
A Phase 4 study testing Daclatasvir + Sofosbuvir and Simeprevir + Sofosbuvir in people with Hepatitis C, Chronic, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Daclatasvir + Sofosbuvir and Simeprevir + Sofosbuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2015to May 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR Never taken DAAs for HCV Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications No Liver Cirrhosis Liver fibrosis Metavir F3 APRI > 1,5 FIB4 > 3,25
Who cannot join
- Infection with HCV other than GT-1 or subjects with mixed infections of any genotype Liver Cirrhosis Evidence of decompensated liver Subjects Infected with HIV-1 Hepatitis B virus (HBV) coinfection Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair Current or known history of cancer Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy Pregnancy or impossibility to use birth control methods by the couple, or breastfeeding Regular use of: erythromycin, clarithromycin, rifampicin, rifabutin, telithromycin, itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole, dexamethasone, cisapride, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), silymarin (Silybum marianum) and some antiarrhythmic drugs such as amiodarone
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Outpatient Clinic of Viral Hepatitis (NUPAIG)
São Paulo, 04025-001
About this study
Official title: Randomized Clinical Trial to Assess the Effectiveness of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1 (TNT-1 Study)
The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1.
Read the detailed description
In this open-label, single-center, head-to-head non-inferiority trial, treatment-naive or pegylated interferon treatment-experienced patients with GT1 infection were randomized to receive once-daily SOF 400 mg plus DCV 60 mg or SIM 150 mg for 12 weeks.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Daclatasvir + Sofosbuvir, Simeprevir + Sofosbuvir
- 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.
Daclatasvir + SofosbuvirDrug
Also called Solvaldi, Daklinza
Sofosbuvir 400 mg tablet + Daclatasvir 60 mg tablet oral dosing once daily for 12 weeks
Simeprevir + SofosbuvirDrug
Also called Sovaldi, Olysio
Sofosbuvir 400 mg tablet + Simeprevir 150 mg tablet oral dosing once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Daclatasvir + Sofosbuvir | Experimental | Daclatasvir 60 mg tablet + Sofosbuvir 400 mg tablet oral dosing once daily for 12 weeks Receives: Drug: Daclatasvir + Sofosbuvir |
| Simeprevir + Sofosbuvir | Experimental | Simeprevir 150 mg tablet + Sofosbuvir 400 mg tablet oral dosing once daily for 12 weeks Receives: Drug: Simeprevir + Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 12 IU/mL at follow-up Week 12
Measured: At follow-up Week 12
Secondary outcomes (4)
Percentage of Subjects With Rapid Virologic Response at Week 4 (RVR)
RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 12 IU/mL at Week 4.
Measured: Week 4
Percentage of Subjects With End of Treatment Response (EOTR)
EOTR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 12 IU/mL at the end of treatment.
Measured: Week 12
Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment.
Measured: From start of study treatment up to 7 days post last dose of study treatment
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Relapse at Follow-up Week 12 (SVR12)
Relapse was defined as hepatitis C virus RNA levels to be > lower limit of quantitation ie, 12 IU/mL at follow-up Week 12
Measured: At follow-up Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrique Pott Junior, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624063
- Sponsor's protocol ID
- TNT
- Status last verified
- Jul 2017
- First submitted
- 2 Dec 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pott-Junior H, Bricks G, Grandi G, Figueiredo Senise J, Castelo Filho A. Sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in noncirrhotic subjects chronically infected with hepatitis C virus genotype 1: a randomized clinical trial. Clin Microbiol Infect. 2019 Mar;25(3):365-371. doi: 10.1016/j.cmi.2018.06.007. Epub 2018 Jun 12.
PubMed 29906601
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Assess the Effectiveness of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1 (TNT-1 Study)
- ClinicalTrials.gov ID
- NCT02624063
- Acronym / sponsor ID
- TNT
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 8 Dec 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.
The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1.
Detailed description
In this open-label, single-center, head-to-head non-inferiority trial, treatment-naive or pegylated interferon treatment-experienced patients with GT1 infection were randomized to receive once-daily SOF 400 mg plus DCV 60 mg or SIM 150 mg for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daclatasvir + Sofosbuvir | Experimental | Drug: Daclatasvir + SofosbuvirDaclatasvir 60 mg tablet + Sofosbuvir 400 mg tablet oral dosing once daily for 12 weeks |
| Simeprevir + Sofosbuvir | Experimental | Drug: Simeprevir + SofosbuvirSimeprevir 150 mg tablet + Sofosbuvir 400 mg tablet oral dosing once daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR Never taken DAAs for HCV Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications No Liver Cirrhosis Liver fibrosis Metavir F3 APRI > 1,5 FIB4 > 3,25
Key exclusion criteria (1 listed)
- Infection with HCV other than GT-1 or subjects with mixed infections of any genotype Liver Cirrhosis Evidence of decompensated liver Subjects Infected with HIV-1 Hepatitis B virus (HBV) coinfection Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair Current or known history of cancer Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy Pregnancy or impossibility to use birth control methods by the couple, or breastfeeding Regular use of: erythromycin, clarithromycin, rifampicin, rifabutin, telithromycin, itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole, dexamethasone, cisapride, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), silymarin (Silybum marianum) and some antiarrhythmic drugs such as amiodarone
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 + SofosbuvirAlso: Solvaldi, DaklinzaSofosbuvir 400 mg tablet + Daclatasvir 60 mg tablet oral dosing once daily for 12 weeks | Drug | Daclatasvir + Sofosbuvir |
| Simeprevir + SofosbuvirAlso: Sovaldi, OlysioSofosbuvir 400 mg tablet + Simeprevir 150 mg tablet oral dosing once daily for 12 weeks | Drug | Simeprevir + Sofosbuvir |
Primary outcome
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Time frame: At follow-up Week 12
SVR12 was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 12 IU/mL at follow-up Week 12
4 secondary outcomes
Percentage of Subjects With Rapid Virologic Response at Week 4 (RVR)
Time frame: Week 4
Percentage of Subjects With End of Treatment Response (EOTR)
Time frame: Week 12
Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment.
Time frame: From start of study treatment up to 7 days post last dose of study treatment
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Relapse at Follow-up Week 12 (SVR12)
Time frame: At follow-up Week 12
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 Aug 2017.
- Derived from this study: PubMed 29906601Pott-Junior H, Bricks G, Grandi G, Figueiredo Senise J, Castelo Filho A. Sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in noncirrhotic subjects chronically infected with hepatitis C virus genotype 1: a randomized clinical trial. Clin Microbiol Infect. 2019 Mar;25(3):365-371. doi: 10.1016/j.cmi.2018.06.007. Epub 2018 Jun 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Daclatasvir + Sofosbuvir and Simeprevir + Sofosbuvir in people with Hepatitis C, Chronic, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 Aug 2017. 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 Brazil. 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?
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) (time frame: At follow-up Week 12). 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 NCT02624063, 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 1 Aug 2017.