Kidney Failure, ChronicPhase 3NCT03883698
Safety of Sofosbuvir in People With Advanced Kidney Failure
A Phase 3 study testing Sofosbuvir and Daclatasvir 60 mg in people with Kidney Failure, Chronic and Hepatitis C, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
Trial summary
Infection with hepatitis C virus (HCV), a hepatotropic RNA virus, is often chronic, and causes liver cirrhosis and liver cancer. The virus is transmitted through parenteral exposure. This infection is particularly common in those on maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Kidney Failure, Chronic, Hepatitis C
- What is being tested?
- Sofosbuvir and Daclatasvir 60 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2019to 1 Aug 2020
- Phase
- Phase 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with:
- hepatitis C virus infection with detectable HCV RNA in blood
- naïve to direct acting antiviral drugs based anti-HCV treatment
Who cannot join
- Hepatitis B virus co-infection
- Human immunodeficiency virus co-infection
- Clinical evidence of cirrhosis or portal hypertension such as ascites, esophageal or gastric varices on esophago-gastro-duodenoscopy, liver stiffness more than 15 KPa as measured with transient elastography or history of hepatic encephalopathy.
Trial locations and contacts
1 site in 1 country.
India1 site
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
About this study
Official title: Pharmacokinetics of Low-dose Sofosbuvir in Dialysis-dependent Patients With Hepatitis C Virus Infection
Infection with hepatitis C virus (HCV), a hepatotropic RNA virus, is often chronic, and causes liver cirrhosis and liver cancer. The virus is transmitted through parenteral exposure. This infection is particularly common in those on maintenance hemodialysis.
Sofosbuvir, an inhibitor of HCV RNA-dependent RNA polymerase, forms the backbone of DAA-based anti-HCV treatment regimens. In pre-clinical pharmacokinetic studies, administration of the usual 400 mg daily dose to in presence of advanced kidney failure (estimated glomerular filtration rate [eGFR] of <30 ml/min) showed that serum levels of the sofosbuvir and GS-331007, the primary metabolite of sofosbuvir, were elevated by several folds. Hence, sofosbuvir is not approved for use in people on maintenance hemodialysis.
Read more
The newer DAAs (e.g. grazoprevir/elbasvir combination), which have been approved for use in people with eGFR <30 ml/min, are very costly and are not available in Asian countries including India. Hence, as a rescue measures, several physicians, including our group, have tried half-daily dose (i.e, 200 mg daily or 400mg on alternate days) of sofosbuvir and 60 mg daclatasvir in dialysis-dependent people, with good results in terms of both safety and efficacy. In fact, the use of this empirical 200 mg daily dose schedule has become common in clinical practice. However, this use is not based on any pharmacokinetic data.
Hence, it is proposed to study the pharmacokinetics of low-dose (200 mg daily or 400 mg alternate day) of sofosbuvir and GS-331007 metabolite in people with eGFR <30/min and active HCV infection.
Read the detailed description
Study design Three arms, observational, pharmacokinetic study
Study duration Two years (March 2019-February 2020)
Study participants Two groups of participants will be included (i) People without chronic kidney disease, i.e, normal eGFR and infected with HCV infection (ii) People with chronic kidney disease and eGFR <30 ml/min and infected with HCV infection
We will include a total of thirty participants with ten in each of the three groups: Group A (ESRD, alternate day dose), Group B (ESRD, daily dose) and Group C (normal eGFR)
Drug schedule Participants with eGFR <30 ml/min: will be given daclatasvir 60 mg once daily along with either sofosbuvir (200 mg) daily once or sofosbuvir 400mg once every alternate day Participants with normal renal function will be treated with sofosbuvir 400mg and daclatasvir 60 mg once daily.
The treatment duration will be 12 weeks for alll there three study groups.
Dialysis schedule A four to five hour hemodialysis sessions will be provided twice in a week
Plan for pharmacokinetic study (i) Molecules: Sofosbuvir and GS331007 (ii) Method: Liquid chromatography-tandem mass spectrometry (iii) Specimen collection (~2 ml each time) will be done as follows: Hour '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 [Day 1]; hour 36 [Day 2]; hour 84 [Day 4], and hour 156 [Day 7].
Sample Collection, Transport and Storage Soon after sample collection, serum will be separated by centrifugation at 4000×g for 10 min at 4°C and separated serum will stored at -80°C till analysis. Analysis will be done using validated bioanalytical method at CSIR-CDRI, Lucknow.
Inactivation of hepatitis C virus in the stored sample HCV inactivation will be done by heat treatment. Before heat treatment, water bath chamber will be cleaned, filled with fresh RO water and temperature calibration will be checked for accuracy. The specimens will be heated at 60 C for 10 minutes or 65 C for 5 minutes to inactivate the virus. Immediately after heat treatment, the specimens will be put in crushed ice to stop the heat effect. The specimens will be transported in frozen condition for analysis.
Sample preparation:
The sample preparation consists of the simple liquid-liquid extraction and/or protein precipitation.
Liquid chromatography-mass spectroscopy HPLC system consisting of Shimadzu UFLC system consisting of LC-20AD binary pumps and SIL-HTc autosampler (Shimadzu Corporation, Kyoto, Japan) will be used to inject 10 µL aliquots of the processed samples on a C18 column (4.6 mm × 50 mm, 5.0 µm). The separation will be achieved by running the mobile phase in isocratic mode containing acetonitrile and 10mM ammonium acetate buffer in suitable ratio (%v/v) at a flow rate capable of sufficient resolution to be optimized during method development and validation. The mobile phase will be duly filtered through 0.22 µm filter and degassed ultrasonically before use. Mass spectrometric detection will be performed on an API 5500 Q Trap mass spectrometer (Applied Biosystems, MDS Sciex Toronto, Canada) equipped with an API electron spray ionization (ESI) source. The ion spray voltage will be set at 5500 V. The instrument related parameters viz., nebulizer gas, curtain gas, auxiliary gas and collision gas and coompound related parameters viz., declustering potential (DP), collision energy (CE), entrance potential (EP) and collision cell exit potential (CXP) respectively will be optimized before validating the method . Zero air will be used as source gas while nitrogen will be used as both curtain and collision gas. The mass spectrometer will be operated at ESI positive as well as ESI negative ion mode and detection of the ions will be performed in the multiple reaction monitoring (MRM) mode monitering the transitions of the analytes. Quadrupole 1 and quadrupole 3 will be maintained at unit resolution and dwell time will be set at 200 ms. Analyst 1.6 software (version 1.6, Built 3773; AB Sciex, Toronto, Canada) will be used for data acquisition and quantitation.
Pharmacokinetic parameters estimation The pharmacokinetic parameters will be estimated using WinNonlin software either through compartment/non-compartment modeling.
- Conditions
- Kidney Failure, Chronic, Hepatitis C
- Being tested
- Sofosbuvir, Daclatasvir 60 mg
- Medical subject headings
- Kidney Failure, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofosbuvirDrug
Sofosbuvir is the backbone of the most of the currently used anti-HCV treatment regimens
Daclatasvir 60 mgDrug
Daclatasvir, in combination with sofosbuvir, is approved for the treatment of hepatitis C virus infection in absence of liver cirrhosis
| Study group | Role | What they receive |
|---|---|---|
| ESRD, alternate day dose | Experimental | Participants with end stage renal disease (eGFR <30 ml/min) and hepatitis C virus active infection and treated with sofosbuvir 400 mg on alternate days. Total duration of treatment will be 12 weeks Receives: Drug: Sofosbuvir; Drug: Daclatasvir 60 mg |
| ESRD, daily dose | Experimental | Participants with end stage renal disease (eGFR <30 ml/min) and hepatitis C virus active infection and treated with sofosbuvir 200 mg daily doses. The total duration of treatment will be 12 weeks Receives: Drug: Sofosbuvir; Drug: Daclatasvir 60 mg |
| Control | Active comparator | Participants with normal eGFR and hepatitis C virus infection and treated with sofosbuvir 400 mg daily dose. The total duration of treatment will be 12 weeks Receives: Drug: Sofosbuvir; Drug: Daclatasvir 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics study
To study the Maximum Plasma Concentration [Cmax] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR.
Measured: At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7
Pharmacokinetics study
To study the Area Under the Curve [AUC] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR.
Measured: At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7
Pharmacokinetics study
To study the Terminal Half Life [t1/2] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR.
Measured: At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7
Secondary outcomes (1)
Clinical response
Proportion of participants with sustained virologic response at 12 weeks [SVR12] after discontinuation of anti-HCV treatment
Measured: 12 weeks after stopping anti-HCV treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start15 Mar 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, 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 3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a three arm, case control study aimed at studying the pharmacokinetics of sofosbuvir and its major metabolite (GS-331007) in people with estimated GFR (eGFR) \<30 ml/min. Two arms will include participants with advanced renal failure with eGFR below 30 ml/min and third arm will include participants with normal eGFR. Participants with eGFR \<30 ml/min will receive sofosbuvir in doses of either 400mg on alternate days or 200mg daily. The participants with normal eGFR will receive the standard of care, i.e, 400mg of sofosbuvir daily
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amit Goel, DM, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883698
- Sponsor's protocol ID
- 2018-167-IMP-107
- Other IDs
- CTRI/2019/03/018011
- Status last verified
- Apr 2021
- First submitted
- 15 Mar 2019
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As of now, our group has not decided about sharing the IPD with other researchers in a publicly available platform. Though, if needed, we could try to share the needed information if our institute's ethic committee permits for the same.
Publications
Kirby BJ, Symonds WT, Kearney BP, Mathias AA. Pharmacokinetic, Pharmacodynamic, and Drug-Interaction Profile of the Hepatitis C Virus NS5B Polymerase Inhibitor Sofosbuvir. Clin Pharmacokinet. 2015 Jul;54(7):677-90. doi: 10.1007/s40262-015-0261-7.
PubMed 25822283European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018 Aug;69(2):461-511. doi: 10.1016/j.jhep.2018.03.026. Epub 2018 Apr 9. No abstract available.
PubMed 29650333Kidney Disease: Improving Global Outcomes (KDIGO) Hepatitis C Work Group. KDIGO 2018 Clinical Practice Guideline for the Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease. Kidney Int Suppl (2011). 2018 Oct;8(3):91-165. doi: 10.1016/j.kisu.2018.06.001. Epub 2018 Sep 19. No abstract available.
PubMed 30675443Goel A, Bhadauria DS, Kaul A, Verma P, Mehrotra M, Gupta A, Sharma RK, Rai P, Aggarwal R. Daclatasvir and reduced-dose sofosbuvir: An effective and pangenotypic treatment for hepatitis C in patients with estimated glomerular filtration rate <30 mL/min. Nephrology (Carlton). 2019 Mar;24(3):316-321. doi: 10.1111/nep.13222.
PubMed 29327401
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Low-dose Sofosbuvir in Dialysis-dependent Patients With Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT03883698
- Acronym / sponsor ID
- 2018-167-IMP-107
- Conditions
- Kidney Failure, Chronic, Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 21 Mar 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.
Infection with hepatitis C virus (HCV), a hepatotropic RNA virus, is often chronic, and causes liver cirrhosis and liver cancer. The virus is transmitted through parenteral exposure. This infection is particularly common in those on maintenance hemodialysis.
Sofosbuvir, an inhibitor of HCV RNA-dependent RNA polymerase, forms the backbone of DAA-based anti-HCV treatment regimens. In pre-clinical pharmacokinetic studies, administration of the usual 400 mg daily dose to in presence of advanced kidney failure (estimated glomerular filtration rate [eGFR] of <30 ml/min) showed that serum levels of the sofosbuvir and GS-331007, the primary metabolite of sofosbuvir, were elevated by several folds. Hence, sofosbuvir is not approved for use in people on maintenance hemodialysis.
The newer DAAs (e.g. grazoprevir/elbasvir combination), which have been approved for use in people with eGFR <30 ml/min, are very costly and are not available in Asian countries including India. Hence, as a rescue measures, several physicians, including our group, have tried half-daily dose (i.e, 200 mg daily or 400mg on alternate days) of sofosbuvir and 60 mg daclatasvir in dialysis-dependent people, with good results in terms of both safety and efficacy. In fact, the use of this empirical 200 mg daily dose schedule has become common in clinical practice. However, this use is not based on any pharmacokinetic data.
Hence, it is proposed to study the pharmacokinetics of low-dose (200 mg daily or 400 mg alternate day) of sofosbuvir and GS-331007 metabolite in people with eGFR <30/min and active HCV infection.
Detailed description
Study design Three arms, observational, pharmacokinetic study
Study duration Two years (March 2019-February 2020)
Study participants Two groups of participants will be included (i) People without chronic kidney disease, i.e, normal eGFR and infected with HCV infection (ii) People with chronic kidney disease and eGFR <30 ml/min and infected with HCV infection
We will include a total of thirty participants with ten in each of the three groups: Group A (ESRD, alternate day dose), Group B (ESRD, daily dose) and Group C (normal eGFR)
Drug schedule Participants with eGFR <30 ml/min: will be given daclatasvir 60 mg once daily along with either sofosbuvir (200 mg) daily once or sofosbuvir 400mg once every alternate day Participants with normal renal function will be treated with sofosbuvir 400mg and daclatasvir 60 mg once daily.
The treatment duration will be 12 weeks for alll there three study groups.
Dialysis schedule A four to five hour hemodialysis sessions will be provided twice in a week
Plan for pharmacokinetic study (i) Molecules: Sofosbuvir and GS331007 (ii) Method: Liquid chromatography-tandem mass spectrometry (iii) Specimen collection (~2 ml each time) will be done as follows: Hour '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 [Day 1]; hour 36 [Day 2]; hour 84 [Day 4], and hour 156 [Day 7].
Sample Collection, Transport and Storage Soon after sample collection, serum will be separated by centrifugation at 4000×g for 10 min at 4°C and separated serum will stored at -80°C till analysis. Analysis will be done using validated bioanalytical method at CSIR-CDRI, Lucknow.
Inactivation of hepatitis C virus in the stored sample HCV inactivation will be done by heat treatment. Before heat treatment, water bath chamber will be cleaned, filled with fresh RO water and temperature calibration will be checked for accuracy. The specimens will be heated at 60 C for 10 minutes or 65 C for 5 minutes to inactivate the virus. Immediately after heat treatment, the specimens will be put in crushed ice to stop the heat effect. The specimens will be transported in frozen condition for analysis.
Sample preparation:
The sample preparation consists of the simple liquid-liquid extraction and/or protein precipitation.
Liquid chromatography-mass spectroscopy HPLC system consisting of Shimadzu UFLC system consisting of LC-20AD binary pumps and SIL-HTc autosampler (Shimadzu Corporation, Kyoto, Japan) will be used to inject 10 µL aliquots of the processed samples on a C18 column (4.6 mm × 50 mm, 5.0 µm). The separation will be achieved by running the mobile phase in isocratic mode containing acetonitrile and 10mM ammonium acetate buffer in suitable ratio (%v/v) at a flow rate capable of sufficient resolution to be optimized during method development and validation. The mobile phase will be duly filtered through 0.22 µm filter and degassed ultrasonically before use. Mass spectrometric detection will be performed on an API 5500 Q Trap mass spectrometer (Applied Biosystems, MDS Sciex Toronto, Canada) equipped with an API electron spray ionization (ESI) source. The ion spray voltage will be set at 5500 V. The instrument related parameters viz., nebulizer gas, curtain gas, auxiliary gas and collision gas and coompound related parameters viz., declustering potential (DP), collision energy (CE), entrance potential (EP) and collision cell exit potential (CXP) respectively will be optimized before validating the method . Zero air will be used as source gas while nitrogen will be used as both curtain and collision gas. The mass spectrometer will be operated at ESI positive as well as ESI negative ion mode and detection of the ions will be performed in the multiple reaction monitoring (MRM) mode monitering the transitions of the analytes. Quadrupole 1 and quadrupole 3 will be maintained at unit resolution and dwell time will be set at 200 ms. Analyst 1.6 software (version 1.6, Built 3773; AB Sciex, Toronto, Canada) will be used for data acquisition and quantitation.
Pharmacokinetic parameters estimation The pharmacokinetic parameters will be estimated using WinNonlin software either through compartment/non-compartment modeling.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three arm, case control study aimed at studying the pharmacokinetics of sofosbuvir and its major metabolite (GS-331007) in people with estimated GFR (eGFR) <30 ml/min. Two arms will include participants with advanced renal failure with eGFR below 30 ml/min and third arm will include participants with normal eGFR. Participants with eGFR <30 ml/min will receive sofosbuvir in doses of either 400mg on alternate days or 200mg daily. The participants with normal eGFR will receive the standard of care, i.e, 400mg of sofosbuvir daily
| Arm | Type | Receives |
|---|---|---|
| ESRD, alternate day dose | Experimental | Drug: Sofosbuvir, Drug: Daclatasvir 60 mgParticipants with end stage renal disease (eGFR <30 ml/min) and hepatitis C virus active infection and treated with sofosbuvir 400 mg on alternate days. Total duration of treatment will be 12 weeks |
| ESRD, daily dose | Experimental | Drug: Sofosbuvir, Drug: Daclatasvir 60 mgParticipants with end stage renal disease (eGFR <30 ml/min) and hepatitis C virus active infection and treated with sofosbuvir 200 mg daily doses. The total duration of treatment will be 12 weeks |
| Control | Active comparator | Drug: Sofosbuvir, Drug: Daclatasvir 60 mgParticipants with normal eGFR and hepatitis C virus infection and treated with sofosbuvir 400 mg daily dose. The total duration of treatment will be 12 weeks |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with:
Key exclusion criteria (3 listed)
- Hepatitis B virus co-infection
- Human immunodeficiency virus co-infection
- Clinical evidence of cirrhosis or portal hypertension such as ascites, esophageal or gastric varices on esophago-gastro-duodenoscopy, liver stiffness more than 15 KPa as measured with transient elastography or history of hepatic encephalopathy.
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 |
|---|---|---|
| SofosbuvirSofosbuvir is the backbone of the most of the currently used anti-HCV treatment regimens | Drug | Control, ESRD, alternate day dose, ESRD, daily dose |
| Daclatasvir 60 mgDaclatasvir, in combination with sofosbuvir, is approved for the treatment of hepatitis C virus infection in absence of liver cirrhosis | Drug | Control, ESRD, alternate day dose, ESRD, daily dose |
Primary outcome
Pharmacokinetics study
Time frame: At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7
To study the Maximum Plasma Concentration [Cmax] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR.
Pharmacokinetics study
Time frame: At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7
To study the Area Under the Curve [AUC] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR.
Pharmacokinetics study
Time frame: At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7
To study the Terminal Half Life [t1/2] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR.
1 secondary outcome
Clinical response
Time frame: 12 weeks after stopping anti-HCV 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 6 Apr 2021.
- Background: PubMed 25822283Kirby BJ, Symonds WT, Kearney BP, Mathias AA. Pharmacokinetic, Pharmacodynamic, and Drug-Interaction Profile of the Hepatitis C Virus NS5B Polymerase Inhibitor Sofosbuvir. Clin Pharmacokinet. 2015 Jul;54(7):677-90. doi: 10.1007/s40262-015-0261-7.
- Background: PubMed 29650333European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018 Aug;69(2):461-511. doi: 10.1016/j.jhep.2018.03.026. Epub 2018 Apr 9. No abstract available.
- Background: PubMed 30675443Kidney Disease: Improving Global Outcomes (KDIGO) Hepatitis C Work Group. KDIGO 2018 Clinical Practice Guideline for the Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease. Kidney Int Suppl (2011). 2018 Oct;8(3):91-165. doi: 10.1016/j.kisu.2018.06.001. Epub 2018 Sep 19. No abstract available.
- Background: PubMed 29327401Goel A, Bhadauria DS, Kaul A, Verma P, Mehrotra M, Gupta A, Sharma RK, Rai P, Aggarwal R. Daclatasvir and reduced-dose sofosbuvir: An effective and pangenotypic treatment for hepatitis C in patients with estimated glomerular filtration rate <30 mL/min. Nephrology (Carlton). 2019 Mar;24(3):316-321. doi: 10.1111/nep.13222.
- Individual participant dataSharing planned: Undecided. As of now, our group has not decided about sharing the IPD with other researchers in a publicly available platform. Though, if needed, we could try to share the needed information if our institute's ethic committee permits for the same.
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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.
Amit Goel, DM principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofosbuvir and Daclatasvir 60 mg in people with Kidney Failure, Chronic and Hepatitis C, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
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 3 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 6 Apr 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 India. 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 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?
Pharmacokinetics study (time frame: At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7). The study lists 3 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 NCT03883698, which also lists 4 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 6 Apr 2021.