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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by MTI Medical Private Limited, Pakistan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
MTI Medical Private Limited, Pakistan
ClinicalTrials.gov Identifier:
NCT01463592
First received: August 30, 2011
Last updated: November 21, 2011
Last verified: October 2011
  Purpose

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.

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.


Condition Intervention Phase
Hepatitis C, Chronic
Biological: RENESSANS , INTERFERON ALPHA 2b, Ribavirin
Drug: Interferon Alfa-2b AND RIBAVIRIN
Biological: RENESSANS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MTI Medical Private Limited, Pakistan:

Primary Outcome Measures:
  • Efficacy of Renessans based triple therapy versus dual therapy [ Time Frame: 03 years ] [ Designated as safety issue: Yes ]
    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].


Secondary Outcome Measures:
  • Assess the safety and tolerability of Renessans in patients with chronic HCV patients [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
    Safety will be assessed by Adverse event and Serious adverse events.


Enrollment: 90
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group II a
TRIPPLE THERAPY
Biological: RENESSANS , INTERFERON ALPHA 2b, Ribavirin
ORAL RENESSANS 5gm. Twice Daily +INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg
Other Names:
  • IODINE POLYMER
  • HEBERON
  • VIRON
Active Comparator: Group II b
DUAL THERAPY
Drug: Interferon Alfa-2b AND RIBAVIRIN
INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg
Other Names:
  • HEBERON
  • VIRON
Experimental: Group I
ORAL RENESSANS
Biological: RENESSANS
ORAL RENESSANS 5gm. Thrice Daily{active iodine 300mg} for 6months
Other Name: IODINE POLYMER

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463592

Locations
Pakistan
Medical Unit 1,Lahore General Hospital,Postgraduate Medical Institute
Lahore, Punjab, Pakistan, 42200
Sponsors and Collaborators
MTI Medical Private Limited, Pakistan
Investigators
Principal Investigator: GHIAS UN NABI, FCPS,MRCP PROFESSOR OF MEDICINE
  More Information

No publications provided

Responsible Party: MTI Medical Private Limited, Pakistan
ClinicalTrials.gov Identifier: NCT01463592     History of Changes
Other Study ID Numbers: REN1
Study First Received: August 30, 2011
Last Updated: November 21, 2011
Health Authority: Pakistan: Ministry of Health

Keywords provided by MTI Medical Private Limited, Pakistan:
Renessans
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferons
Ribavirin
Iodine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Infective Agents, Local
Trace Elements
Micronutrients
Growth Substances
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014