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Albinterferon alfa 2b

Phase 2

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

Albinterferon alfa 2b development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2008

Albinterferon alfa 2b target and mechanism

Molecular targetIFNAR1, IFNAR2
Target classAgonist
ModalityMonoclonal antibody

Also known as ABF656

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

Albinterferon alfa 2b clinical trials

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 therapy being studied for the treatment of chronic hepatitis C, a viral infection of the liver. It is designed to be given less frequently than standard interferon-based regimens. It has been tested in patients with chronic hepatitis C, including genotype 2 and 3 infections.

How does albinterferon alfa 2b work?

Albinterferon alfa 2b is an agonist that targets the interferon alpha receptors IFNAR1 and IFNAR2. By binding to and activating these receptors, it mimics the body's natural interferon alpha signaling, which triggers antiviral responses in cells. This mechanism is intended to help the immune system fight hepatitis C virus infection.

Who is developing albinterferon alfa 2b?

Albinterferon alfa 2b is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the company responsible for the clinical development of this investigational hepatitis C therapy.

What phase is albinterferon alfa 2b in?

Albinterferon alfa 2b is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 program has been completed, and no active trials are currently listed for this candidate.

What clinical trials is albinterferon alfa 2b in?

Albinterferon alfa 2b has been studied in two completed clinical trials. NCT00759200 was a Phase 2 trial evaluating safety and efficacy when administered every 4 weeks in genotype 2/3 hepatitis C patients, enrolling 525 participants across multiple countries. NCT00724776 was a Phase 1 single-dose trial in 30 Japanese chronic hepatitis C patients.

Is albinterferon alfa 2b the same as alb-interferon alfa 2b?

Yes, albinterferon alfa 2b and alb-interferon alfa 2b refer to the same investigational drug. The hyphenated spelling is an alternative name for the same compound being developed by Novartis for chronic hepatitis C.