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C.E.R.A

Phase 1

Anemia | Small molecule | Hematology |Roche Holding AG|Last Updated: Mar 1, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

C.E.R.A · 1 trial · 1 indication

Phase 1 1
NCT00360347A Study of Mircera in Anemic Patients With Multiple MyelomaAnemia
COMPLETED- Analytics
PHASE1COMPLETED
A Study of Mircera in Anemic Patients With Multiple Myeloma
Anemia
NCT00360347-
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Study Endpoints

Primary Endpoints

Hemoglobin level, and change from baseline, at week 6

Secondary Endpoints

Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
C.E.R.A.DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * adult patients, \>=18 years of age; * confirmed diagnosis of multiple myeloma; * anemia (hemoglobin \<=11g/dL at screening visit). Exclusion Criteria: * transfusion of red blood cells during 2 months prior to first planned dose of study medication; * therapy-resistant hypert...

Countries:CzechiaPoland
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Competitive Landscape -Anemia 17 trials

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY2PHASE3ACE-536
Akebia Therapeutics, Inc.AKBA3PHASE3Erythropoiesis-Stimulating Agent, Vadadustat
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Elritercept, Epoetin Alfa
Cerus CorporationCERS1PHASE3Undisclosed
Disc Medicine, Inc.IRON2PHASE2DISC-0974
Incyte CorporationINCY1PHASE1INCB000928, ruxolitinib
Sunshine Biopharma IncorporatedSBFM1PHASE2SSS06, rhEPO
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1APG-5918
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Frequently asked questions about C.E.R.A

What is C.E.R.A used for?

C.E.R.A is an investigational small molecule being developed for the treatment of anemia. It is currently in Phase 1 clinical development. The drug is being studied in anemic patients, including those with multiple myeloma, as part of ongoing research in the hematology therapeutic area.

Who makes C.E.R.A?

C.E.R.A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational drug for the treatment of anemia. Roche is responsible for the development and potential commercialization of C.E.R.A.

What phase is C.E.R.A in?

C.E.R.A is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of anemia, with one completed Phase 1 trial to date.

What clinical trials is C.E.R.A in?

C.E.R.A has been studied in one clinical trial with the identifier NCT00360347, titled 'A Study of Mircera in Anemic Patients With Multiple Myeloma'. This Phase 1 trial was completed and conducted in Czechia and Poland, enrolling adult patients with anemia.

Is C.E.R.A the same as Mircera?

Yes, C.E.R.A is also known as Mircera. The clinical trial NCT00360347, which studied C.E.R.A in anemic patients with multiple myeloma, used the name Mircera in its title. Both names refer to the same investigational drug being developed by Roche.