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AzTrials

Hepatitis C, ChronicPhase 3NCT01463592

To Study the Efficacy and Safety of Renessans in Chronic HCV Patients

A Phase 3 study testing RENESSANS , INTERFERON ALPHA 2b, Ribavirin, Interferon Alfa-2b AND RIBAVIRIN and RENESSANS in people with Hepatitis C, Chronic, run by MTI Medical Private Limited, Pakistan at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic HCV infection is one of the common causes of the chronic liver disease. Approximately 6-10% of the general public is expected to be suffering from this infection. In case that these patients are not treated at an appropriate time, these patients develop the sequelae of the chronic liver disease e.g. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
RENESSANS , INTERFERON ALPHA 2b, Ribavirin, Interferon Alfa-2b AND RIBAVIRIN and RENESSANS
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 sitePakistan
Study dates
Jun 2010to Dec 2013
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Following groups of the people will be enrolled for the study.
  • Patients suffering from chronic HCV infection as evident with a positive serology for Anti HCV antibody and raised ALT.
  • Both males and females
  • Age group: 18 - 55 years
  • Informed consent

Who cannot join

  • Following groups of people will be excluded from the study
  • Pregnant females
  • Body mass index more than 25
  • Uncontrolled Diabetes Mellitus, Hypertension, Ischemic heart disease, Renal failure, Respiratory failure, Chronic infections, gall stone disease or renal stone disease.
  • Patients known to have hypersensitivity to Iodine compounds in the past.
  • Psychiatric disorders except mild anxiety disorders.
Show all 11Show fewer
  • Patients suffering from auto immune diseases e.g. Rheumatoid Arthritis, SLE, or thyroid diseases.
  • Patients suffering from concomitant HBV infection, HIV infection or any other chronic liver disease.
  • Bilirubin more than 2mg/dl, Albumin less than 3.0 gms/dl, INR more than 1.5, Hb. less than 10 gms /dl, absolute neutrophil count less than 1500/cmm and platelet count less than 100,000/cmm
  • Serum sodium less than 130mmol/l.
  • Patients who have received the interferon treatment in the past.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Medical Unit 1,Lahore General Hospital,Postgraduate Medical Institute

    Lahore, Punjab Province, 42200

Other trials in Pakistan

About this study

Official title: An Open Labelled, Active Controlled, Three Arm, Parallel- Group Study of the Safety and Efficacy of Renessans Administered Alone and in Combination With Standard Interferon Therapy in Patients Chronic HCV Hepatitis

Chronic HCV infection is one of the common causes of the chronic liver disease. Approximately 6-10% of the general public is expected to be suffering from this infection. In case that these patients are not treated at an appropriate time, these patients develop the sequelae of the chronic liver disease e.g. cirrhosis of liver, Ascites, and Hepatocellular carinoma. Interferon alpha 2 a or alpha 2b injections and Ribavirin combination is the treatment of choice for people suffering from Chronic HCV infection and this combination need to be administered for 6-12 months. Interferons are biological agents and are to be administered parenterally. Interferons are expensive and are associated with number of minor and major adverse effects. Ribavirin is also associated with significant adverse effects. These compounds cannot be considered as one of the ideal forms of the treatment.

In the past, quite a few natural products have been tested to assess their hepatoprotective activity and possibly anti viral activity as well. These include Vitamin C (Ascorbic acid), Vitamin E, Zinc, Silymarin, Red beet roots, crushed licorice and etc. etc.

Read more

Rationale Iodine , Potassium iodide and Ascorbic acid are natural products used in the management of Thyroiditis and chronic cutaneous fungal infections. This combination of iodine compounds along with ascorbic acid is being used for the management of chronic hepatitis B \& C in the central Asian states e.g. Kazakhstan etc.

The investigators have conducted a feasibility study in which oral Iodine Compound {RENESSANS} was given to patients suffering HCV related Chronic Active Hepatitis and anti-viral activity and safety has been analyzed. In this study, RENESSANS containing regimen has been well tolerated by all the patients and has shown some antiviral activity.

In this study the investigators will assess whether the administration of RENESSANS {oral } improves the antiviral activity in patients receiving standard interferon therapy.

Read the detailed description
  1. Primary The primary objective of this study is to assess the efficacy of combination therapy comprising of RENESSANS, INTERFERONS and RIBAVIRIN in the management of treatment naïve HCV related Chronic Active Hepatitis patients.
  2. Secondary The secondary objectives of this study are:
  3. Determine the biochemical or virological improvement in patients suffering from HCV related Chronic Active Hepatitis.
  4. Determine the safety and tolerability of Renessans {oral} when administered as a part of antiviral activity outlined in this protocol.
  5. ENDPOINTS The primary endpoint will be the number of subjects achieving
  6. Virological response as evident by Rapid Viral Response(RVR), Early Viral Response(EVR) and Sustained Viral Response(SVR).
  7. Biochemical response as evident by normalization of ALT. The secondary endpoint will be
  8. Assessment of the safety and tolerability of RENESSANS through: routine physical examination, routine clinical laboratory tests, clinical monitoring and adverse events reporting.
  9. INVESTIGATIONAL PLAN Study Design. This is an open labeled, active controlled, three arm, parallel-group study of the safety and efficacy of the oral formulation of natural iodine compound (Renessans) administered alone and in combination with standard interferon therapy in patient suffering from chronic HCV hepatitis. The enrolled patients will be tested for following base line laboratory tests VISIT 1: CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes Thyroid Function tests HBsAg, HIV antibody Urinalysis ANA, RA factor and serum ferritin levels USG of abdomen HCV RNA (PCR by amplicor, roche) qualitative analysis, if positive then quantitative analysis (Real time) and genotype as well. Pregnancy test in case of females Informed consent shall be obtained and each individual patient's treatment risk shall be covered under a certified health insurance plan. Renessans will be administered in eligible patients as follows: Study Arm Dosing Schema Group I ORAL RENESSANS 5gm. Thrice Daily{active iodine 300mg} for 6months Group II a ORAL RENESSANS 5gm. Twice Daily +INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg Group II b INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg Blood samples shall be collected and stored for post - hoc analysis of HCV RNA at day 1, 7 and 15(visit 2,3 \& 4). Patients will be reviewed for the hepatoprotection, anti viral activity and any adverse event every four weeks with following clinical and lab work. VISIT 5 Detailed history and physical examination Following lab. Investigations at week 4. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes Thyroid Function tests Ferritin HCV RNA (PCR) quantitative analysis VISIT 6 Detailed history and physical examination Following lab. Investigations at week 8. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 7 Detailed history and physical examination Following lab. Investigations at week 12. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes Thyroid Function tests Ferritin HCV RNA (PCR) quantitative analysis VISIT 8 Detailed history and physical examination Following lab. Investigations at week 16. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 9 Detailed history and physical examination Following lab. Investigations at week 20. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 10 Detailed history and physical examination Following lab. Investigations at week 24. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 11 Detailed history and physical examination Following lab. Investigations at week 28. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 12 Detailed history and physical examination Following lab. Investigations at week 32. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 13 Detailed history and physical examination Following lab. Investigations at week 36. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 14 Detailed history and physical examination Following lab. Investigations at week 40. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 15 Detailed history and physical examination Following lab. Investigations at week 44. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 16 Detailed history and physical examination Following lab. Investigations at week 48. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 15 Detailed history and physical examination Following lab. Investigations at week 52. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 15 Detailed history and physical examination Following lab. Investigations at week 60. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT 16 Detailed history and physical examination Following lab. Investigations at week 72. CBC including platelet count and ESR Liver function tests including albumin and total proteins. Creatinine Serum electrolytes Thyroid Function tests Ferritin HCV RNA (PCR) quantitative analysis
Being tested
RENESSANS , INTERFERON ALPHA 2b, Ribavirin, Interferon Alfa-2b AND RIBAVIRIN, RENESSANS
Keywords
Renessans, HCV
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.

  • RENESSANS , INTERFERON ALPHA 2b, RibavirinBiological

    Also called IODINE POLYMER, HEBERON, VIRON

    ORAL RENESSANS 5gm. Twice Daily +INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg

  • Interferon Alfa-2b AND RIBAVIRINDrug

    Also called HEBERON, VIRON

    INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg

  • RENESSANSBiological

    Also called IODINE POLYMER

    ORAL RENESSANS 5gm. Thrice Daily{active iodine 300mg} for 6months

Study groups in NCT01463592
Study groupRoleWhat they receive
Group II aExperimentalTRIPPLE THERAPY
Receives: Biological: RENESSANS , INTERFERON ALPHA 2b, Ribavirin
Group II bActive comparatorDUAL THERAPY
Receives: Drug: Interferon Alfa-2b AND RIBAVIRIN
Group IExperimentalORAL RENESSANS
Receives: Biological: RENESSANS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Renessans based triple therapy versus dual therapy

    Efficacy will be assessed by biochemical and virological response. Biochemical response will be assessed in the form of mean decline in ALT from baseline at 3 month and end of treatment. Virological response will be assessed in the form of response guided therapy i-e RVR [negative RNA at week 4],EVR [negative RNA at 12 weeks],ETR [negative RNA at end of treatment] and SVR[negative PCR after 6 month of completion of therapy].

    Measured: 03 years

Secondary outcomes (1)

  1. Assess the safety and tolerability of Renessans in patients with chronic HCV patients

    Safety will be assessed by Adverse event and Serious adverse events.

    Measured: 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01463592
Sponsor's protocol ID
REN1
Status last verified
Oct 2011
First submitted
30 Aug 2011
Last updated
22 Nov 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RENESSANS , INTERFERON ALPHA 2b, Ribavirin, Interferon Alfa-2b AND RIBAVIRIN and RENESSANS in people with Hepatitis C, Chronic, run by MTI Medical Private Limited, 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 11 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: status not confirmed, as of the sponsor's last update on 22 Nov 2011. 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 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?

Results are not available in the source record.

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?

Efficacy of Renessans based triple therapy versus dual therapy (time frame: 03 years). 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 NCT01463592.

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 22 Nov 2011.

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