The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,380

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 236 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Experimental
  Pegylated-interferon Alfa-2a + Ribavirin (Group A)

  Participants with HCV RNA levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, will receive pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 milligrams (mg) orally daily for 48 weeks.

  Drug: Pegylated-interferon Alfa-2a · Drug: Ribavirin

• Experimental
  Pegylated-interferon Alfa-2a + Ribavirin (Group B)

  Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.

  Drug: Pegylated-interferon Alfa-2a · Drug: Ribavirin

• Experimental
  Pegylated-interferon Alfa-2a + Ribavirin (Group C)

  Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.

  Drug: Pegylated-interferon Alfa-2a · Drug: Ribavirin

• Experimental
  Pegylated-interferon Alfa-2a + Ribavirin (Group D)

  Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.

  Drug: Pegylated-interferon Alfa-2a · Drug: Ribavirin

• Experimental
  Pegylated-interferon Alfa-2a + Ribavirin (Group E)

  Participants with HCV-RNA levels \<15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.

  Drug: Pegylated-interferon Alfa-2a · Drug: Ribavirin

• Experimental
  Pegylated-interferon Alfa-2a + Ribavirin (Group F)

  Participants with HCV-RNA levels \<15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.

  Drug: Pegylated-interferon Alfa-2a · Drug: Ribavirin

• Experimental
  Pegylated-interferon Alfa-2a + Ribavirin (Group NR)

  Participants who do not have any change in HCV-RNA levels at Weeks 4, 8, and 12 will not be randomized (NR) to any of the other groups. Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.

  Drug: Pegylated-interferon Alfa-2a · Drug: Ribavirin

Interventions

• DrugPegylated-interferon Alfa-2a

  Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.

  Also known as: Pegasys

• DrugRibavirin

  Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.

  Also known as: Copegus

Primary outcomes

1. Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)

   SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.

   Time frame: At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)

Secondary outcomes

1. Percentage of Participants With SVR (Groups C, D, E, and F)

   SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.

   Time frame: At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)

2. Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)

   End of treatment response (ETR) was defined as "Success" if the HCV-RNA levels were \<15 IU/mL at the end of treatment. Early virological response (EVR) was defined as \>=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (\<15 IU/mL) at Week 12. Complete EVR was defined as "Success", if the HCV-RNA levels were \<15 IU/mL at Week 12. Partial EVR was defined as "Success", if there was a \>=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still \>=15 IU/mL at that time point.

   Time frame: Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)

Baseline characteristics

Publications

• Lee SS, Sherman M, Ramji A, Greenbloom S, Elkashab M, Pluta H, Hilzenrat N, Balshaw R, Usaty C, Myers RP. Randomised clinical trial: the efficacy of treatment, guided by a shorter duration of response, using peginterferon alfa-2a plus ribavirin for hepatitis C virus other than genotypes 2 or 3. Aliment Pharmacol Ther. 2012 Jan;35(1):37-47. doi: 10.1111/j.1365-2036.2011.04911.x. Epub 2011 Nov 2. PubMed 22050141 ↗