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Nucleoside Analogues

Phase 2

Hepatitis B, Chronic | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Feb 20, 2017

Target and mechanism

ModalitySmall molecule

Also known as Nucleos(t)ide Analogues (NA)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

Nucleoside Analogues · 1 trial · 1 indication

Phase 2 1
NCT01706575A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) SuppressionHepatitis B, Chronic
COMPLETED76 Analytics
PHASE2COMPLETED
A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
Hepatitis B, Chronic
NCT0170657576
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Study Endpoints

Primary Endpoints

Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)
Baseline up to Week 48
Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)
Baseline and Week 48

Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.

Secondary Endpoints

Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96
Baseline, Week 24, 72 and 96
Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48
Baseline, Week 48
Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96
Week 12 up to Week 96
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pegylated Interferon (Peginterferon) Alfa-2aEXPERIMENTALParticipants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than \<0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.

Interventions

NameTypeDescription
Pegylated Interferon (Peginterferon) Alfa-2aDRUGPeginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.
Nucleos(t)ide Analogues (NA)DRUGNucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Adult participants, 18 - 65 years of age * Chronic hepatitis B * Negative for HBeAg * On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months * HBsAg \>100 IU/ml at the beginning of the Le...

Countries:Italy
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