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Albinterferon alfa 2b

Phase 2

Chronic Hepatitis C | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 8, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment555

FDA Designations

No designations recorded

Clinical trial landscape

Albinterferon alfa 2b · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00759200Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C PatientsChronic Hepatitis C
COMPLETED525 Analytics
PHASE2COMPLETED
Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
Chronic Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events
at every visit
Safety and tolerability after single dose
5 weeks after single dose

Secondary Endpoints

Viral load
at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.
Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
5 weeks after single dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
alb-interferon arm 1EXPERIMENTAL -
alb-interferon arm 2EXPERIMENTAL -
alb-interferon arm 3EXPERIMENTAL -
alb-interferon arm 4EXPERIMENTAL -
peg-interferonACTIVE_COMPARATOR -
1EXPERIMENTALOpen-label treatment with albinterferon alfa 2b escalating single dose

Interventions

NameTypeDescription
alb-interferon alfa 2bDRUG900 mcg every 4 weeks
peg-interferonDRUGPeg-interferon alfa 2a: 180 mcg 1x per wk.
Albinterferon alfa 2bBIOLOGICALrecombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites55

Inclusion Criteria: * Age of 18 years or older * Clinical diagnosis of chronic hepatitis C * Infection with HCV genotype 2 or 3 * No previous IFNα-based therapy Exclusion Criteria: * Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing * Fertil...

Countries:AustraliaCanadaFranceGermanyGreeceIndiaItalyPolandSpainTaiwanThailandUnited KingdomJapan
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Frequently asked questions about Albinterferon alfa 2b

What is Albinterferon alfa 2b used for?

Albinterferon alfa 2b is an investigational drug being developed for the treatment of Chronic Hepatitis C. It is a monoclonal antibody designed to target the condition, and it is currently in Phase 2 clinical development. The drug is not yet approved and remains under investigation for this infectious disease indication.

What does Albinterferon alfa 2b target?

Albinterferon alfa 2b targets Chronic Hepatitis C, a viral infection of the liver. As a monoclonal antibody, it is designed to interfere with the disease process. The drug is being studied to evaluate its safety and efficacy in patients with this condition, though its specific molecular target is not detailed.

Who makes Albinterferon alfa 2b?

Albinterferon alfa 2b is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Chronic Hepatitis C.

What phase is Albinterferon alfa 2b in?

Albinterferon alfa 2b is currently in Phase 2 clinical development for Chronic Hepatitis C. It has completed two clinical trials, including a Phase 1 study and a Phase 2 study, with a total enrollment of 555 participants. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is Albinterferon alfa 2b in?

Albinterferon alfa 2b has been studied in two completed clinical trials. The first, NCT00724776, was a Phase 1 single-dose study in Japanese patients with Chronic Hepatitis C, enrolling 30 participants. The second, NCT00759200, was a Phase 2 safety and efficacy study of the drug administered every 4 weeks in genotype 2/3 hepatitis C patients, enrolling 525 participants across multiple countries.

Is Albinterferon alfa 2b the same as albumin interferon?

Albinterferon alfa 2b is also referred to as albumin interferon, as indicated by the title of one of its clinical trials, which studied the safety and efficacy of albumin interferon administered every 4 weeks. The drug is a single agent being developed by Novartis AG for Chronic Hepatitis C.