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Trial record 1 of 1848 for:    "Hepatitis, Chronic"
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Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium (GCNI-CHC)

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ClinicalTrials.gov Identifier: NCT02799355
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital

May 18, 2016
June 14, 2016
September 27, 2016
May 2016
September 2016   (Final data collection date for primary outcome measure)
Proportion of patients with sustained virologic response at 12 weeks after the end of treatment. [ Time Frame: 3 month ]
Sustained virologic response was defined as a level of HCV RNA below the lower limit of quantification (25 IU per milliliter)
Same as current
Complete list of historical versions of study NCT02799355 on ClinicalTrials.gov Archive Site
Side effect [ Time Frame: 3 month ]
Assess the treatment side effect
Same as current
Not Provided
Not Provided
 
Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium
Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium
Of the six main genotypes of the hepatitis C virus (HCV), genotypes 2 and 3 account for approximately 30% of chronic infections worldwide. In North India, Genotypes 3 and 1 account for 95% of chronic hepatitis C patients The first three direct-acting antiviral agents to receive FDA approval—boceprevir, telaprevir, and simeprevir—do not currently have a role in the treatment of genotype 3 infection. In contrast, the direct-acting antiviral agents, daclatasvir and sofosbuvir, have good activity against all genotypes. The SVR rates of 90 - 100% in genotype 3 were achieved with oral sofosbuvir plus ribavirin regimen to 24 weeks. Similar SVR rates were achieved in Genotype 1 with oral sofosbuvir plus weight based ribavirin and Pegylated Interferon alpha 2 a. However, the ongoing discovery and development of agents that directly target various stages of HCV replication are likely to provide HCV-infected patients with effective interferon-free therapy. HCV genotype 3 infection is associated with a higher incidence of hepatic steatosis, more rapid progression of fibrosis, and possibly a greater risk of hepatocellular carcinoma than is HCV genotype 2 infection.Moreover, patients with HCV genotype 3 infection are less responsive to peginterferon based treatment than are patients with HCV genotype 2 infection.
Sofosbuvir is an oral nucleotide analogue inhibitor of the HCV NS5B polymerase that is effective against HCV genotypes 2 and 3 when it is administered in combination with weight based ribavirin for 24 weeks. In Genotype 1, a combination of Pegylated Interferon alpha 2 a with oral Sofosbuvir and weight based Ribavirin for 12 weeks resulted in 90 -100 % sustained virological response rates (SVR). These SVR rates for chronic hepatitis C genotypes 1,2 and 3 are all based on Western studies. The investigators plan to conduct a retrospective study in Northern India region on patients treated with Sofosbuvir and Ribavirin or Sofosbuvir, Ribavirin and Peginterferon alpha 2a. The purpose of the investigators study is to assess the percentage of patients with sustained virologic response.
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
The study is a retrospective study conducted on 1500 to 2000 patients who have recieved treatment of Sofosbuvir and Ribavirin or Sofosbuvir, Ribavirin and peg interferon alpha 2a
Hepatitis, Chronic
Drug: Sofosbuvir, Ribavirin, With or Without Pegylated Interferon
Retrospective will carried out to find percentage of patients with sustained virologic response at 12 weeks after the end of treatment
Other Name: Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1203
1500
September 2016
September 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age more then 18 years.
  • Patient who on treatment of either Sofosbuvir and Ribavirin (24 weeks) or Sofosbuvir, Ribavirin and peginterferon (12 weeks).

Exclusion Criteria:

  • Patient who are lost to follow up.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT02799355
GCNI-CHC
Yes
Not Provided
Plan to Share IPD: Undecided
Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital
Dayanand Medical College and Hospital
Not Provided
Not Provided
Dayanand Medical College and Hospital
September 2016