Hepatitis C, ChronicPhase 4HEP-C-FMNCT01770483
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
A Phase 4 study testing nitazoxanide, conventional interferon alfa and Ribavirin in people with Hepatitis C, Chronic and DIABETES MELLITUS Type 2, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
The purpose of this study is to investigate if nitazoxanide used in combination with interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic patients by improving their sustained viral response by more than 80%.Considering that the study is being conducted in a third world country… Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Hepatitis C, Chronic, DIABETES MELLITUS Type 2
- What is being tested?
- nitazoxanide, conventional interferon alfa and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2011to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hepatitis C genotype 3a
- Hepatitis C Virus(PCR)RNA Detected
- Alanine transaminase >60
- Diabetic HbA1c<8
- BMI>23
Who cannot join
- Previously treated Hepatitis C patients
- Pregnant females
- Decompensated liver disease,Child class B OR above
- Thyroid disease,Thyroid stimulating hormone>10,0.05
- Absolute neutrophil count<1500,Platelets<80,000,Hb<10g Female,<11g Male
- Severe cardiac disease,New York Heart Association2
- Moderate to severe depression assessed by Beck Depression Inventory scale
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Endocrinology and Diabetes management centre
Lahore, Punjab Province
About this study
The purpose of this study is to investigate if nitazoxanide used in combination with interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic patients by improving their sustained viral response by more than 80%.Considering that the study is being conducted in a third world country like Pakistan, the standard treatment of hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in efficacy to peginterferon and also cost effective.
Read the detailed description
After taking proper informed consent from patients, patients who fulfill the research criteria are randomized into 2 groups (control/study). Patients in both groups will be treated with conventional interferon alfa and Ribavirin.Those in study group will be given tab nitazoxanide 500mg twice daily in addition to conventional treatment. The patients will be followed up at regular intervals: 0,4,12,24,48 week.At each visit Hepatitis C Virus(PCR)RNA, Liver function tests, complete blood count will be done.
- Conditions
- Hepatitis C, Chronic, DIABETES MELLITUS Type 2
- Being tested
- nitazoxanide, conventional interferon alfa, Ribavirin
- Keywords
- Nitazoxanide,, Sustained viral response, Type 2 DIABETICS
- Medical subject headings
- Hepatitis C, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitazoxanideDrug
Also called tablet nizonide500mg, tablet atizox500mg
nitazoxanide 500mg twice daily
conventional interferon alfaDrug
Also called Inj uniferon 3 Million International Units
Inj interferon 3 Million International Units thrice weekly
RibavirinDrug
Also called Ribavirin 400mg-1200mg
ribazole
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months Receives: Drug: nitazoxanide; Drug: conventional interferon alfa; Drug: Ribavirin |
| control group | Active comparator | Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months Receives: Drug: conventional interferon alfa; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral Response,
Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
Measured: 48 WEEK
Secondary outcomes (1)
Normalization of Alanine Transferase Test
Liver function test,showing resolution of the inflammation of liver parenchyma
Measured: 48week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJul 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Collaborators
- Getz Pharma
- Responsible party
- Principal investigator, Prof. Faisal Masud, Services Institute of Medical Sciences, Pakistan
- Investigators
- FAISAL MASUD, FRCP, Study director, Principal SIMS/Services hospital lahoreAMENA MIRZA, MRCP,FCPS, Principal investigator, Senior registrar ,Services hospital lahore/SIMSMadiha Fida, MBBS, Principal investigator, House Officer Services Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770483
- Sponsor's protocol ID
- SIMS
- Acronym
- HEP-C-FM
- Status last verified
- Sep 2013
- First submitted
- 8 Jan 2013
- Last updated
- 20 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01770483
- Acronym / sponsor ID
- HEP-C-FM / SIMS
- Conditions
- Hepatitis C, Chronic, DIABETES MELLITUS Type 2
- Keywords
- Nitazoxanide,, Sustained viral response, Type 2 DIABETICS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Collaborators
- Getz Pharma
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Posted 17 Apr 2013
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 this study is to investigate if nitazoxanide used in combination with interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic patients by improving their sustained viral response by more than 80%.Considering that the study is being conducted in a third world country like Pakistan, the standard treatment of hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in efficacy to peginterferon and also cost effective.
Detailed description
After taking proper informed consent from patients, patients who fulfill the research criteria are randomized into 2 groups (control/study). Patients in both groups will be treated with conventional interferon alfa and Ribavirin.Those in study group will be given tab nitazoxanide 500mg twice daily in addition to conventional treatment. The patients will be followed up at regular intervals: 0,4,12,24,48 week.At each visit Hepatitis C Virus(PCR)RNA, Liver function tests, complete blood count will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: nitazoxanide, Drug: conventional interferon alfa, Drug: RibavirinTablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months |
| control group | Active comparator | Drug: conventional interferon alfa, Drug: RibavirinInjection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Hepatitis C genotype 3a
- Hepatitis C Virus(PCR)RNA Detected
- Alanine transaminase >60
- Diabetic HbA1c<8
- BMI>23
Key exclusion criteria (7 listed)
- Previously treated Hepatitis C patients
- Pregnant females
- Decompensated liver disease,Child class B OR above
- Thyroid disease,Thyroid stimulating hormone>10,0.05
- Absolute neutrophil count<1500,Platelets<80,000,Hb<10g Female,<11g Male
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 |
|---|---|---|
| nitazoxanideAlso: tablet nizonide500mg, tablet atizox500mgnitazoxanide 500mg twice daily | Drug | study group |
| conventional interferon alfaAlso: Inj uniferon 3 Million International UnitsInj interferon 3 Million International Units thrice weekly | Drug | control group, study group |
| RibavirinAlso: Ribavirin 400mg-1200mgribazole | Drug | control group, study group |
Primary outcome
Sustained Viral Response,
Time frame: 48 WEEK
Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
1 secondary outcome
Normalization of Alanine Transferase Test
Time frame: 48week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
FAISAL MASUD, FRCP study director
Principal SIMS/Services hospital lahore
AMENA MIRZA, MRCP,FCPS principal investigator
Senior registrar ,Services hospital lahore/SIMS
Madiha Fida, MBBS principal investigator
House Officer Services Hospital Lahore
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 nitazoxanide, conventional interferon alfa and Ribavirin in people with Hepatitis C, Chronic and DIABETES MELLITUS Type 2, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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 7 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 20 Sep 2013. 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 Pakistan. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sustained Viral Response, (time frame: 48 WEEK). 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 20 Sep 2013.