- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403374
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia (RAMAN)
November 13, 2020 updated by: Amgen
A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India
To describe the safety and tolerability of evolocumab in participants with homozygous familial hypercholesterolemia (HoFH) in India.
All participants will receive evolocumab over an 8-week period.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
An open-label, multicentre, phase 4 study to describe the safety and tolerability of evolocumab in 30 Indian participants with HoFH.
Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial.
Participants will receive evolocumab 420 mg subcutaneous (SC) once monthly (QM) and study visits will occur approximately every 4 weeks.
Apheresis participants will receive evolocumab 420 mg SC every 2 weeks to correspond with their apheresis schedule.
Final administration of evolocumab (for all participants) will occur at week 8.
The end of study (EOS) visit will occur at week 12 for all participants.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delhi
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New Delhi, Delhi, India, 110 060
- Research Site
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New Delhi, Delhi, India, 110 029
- Research Site
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New Delhi, Delhi, India, 110 002
- Research Site
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New Delhi, Delhi, India, 110 062
- Research Site
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Gujarat
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Ahmedabad, Gujarat, India, 380 054
- Research Site
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Karnataka
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Bangalore, Karnataka, India, 560 017
- Research Site
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Belagavi, Karnataka, India, 590010
- Research Site
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Kerala
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Kochi, Kerala, India, 682 027
- Research Site
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Maharashtra
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Mumbai, Maharashtra, India, 400 007
- Research Site
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Pune, Maharashtra, India, 411 005
- Research Site
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Pune, Maharashtra, India, 411 006
- Research Site
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226 003
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female ≥ 12 to ≤ 80 years of age at the time of signing the informed consent
- Diagnosis of HoFH based on low-density lipoprotein cholesterol (LDL-C), familial history and xanthoma
- On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial
- Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)
- Fasting triglycerides at screening ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
- Use of mipomersen or lomitapide within 6 months of screening.
- Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies)
- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed
- Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception
- Subject has known sensitivity to any of the products to be administered during dosing
- History or evidence of any other clinically significant disorder, condition or disease
- Subject has previously received evolocumab or any other proprotein convertase subtilisin/kexin type 9 (PKSK-9)-inhibiting therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Evolocumab
Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).
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Administered by SC injection via autoinjector (AI)/pen
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 12 weeks
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Includes both serious and non-serious adverse events (AEs).
AE: any untoward medical occurrence in a participant.
SAE: an AE that meets 1 on the following serious criteria: fatal; life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event.
TEAE: any AE starting on or after the first dose of study drug and up to and including 30 days after the end of study drug or the end of study date, whichever is earlier.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame: baseline, week 12
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baseline, week 12
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Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
Time Frame: baseline, week 12
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baseline, week 12
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Percent Change From Baseline to Week 12 in Lipoprotein(a) (Lp[a])
Time Frame: baseline, week 12
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baseline, week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2018
Primary Completion (Actual)
November 27, 2019
Study Completion (Actual)
November 27, 2019
Study Registration Dates
First Submitted
January 3, 2018
First Submitted That Met QC Criteria
January 17, 2018
First Posted (Actual)
January 18, 2018
Study Record Updates
Last Update Posted (Actual)
November 27, 2020
Last Update Submitted That Met QC Criteria
November 13, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Hypercholesterolemia
- Hyperlipoproteinemia Type II
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Evolocumab
Other Study ID Numbers
- 20170199
- 2020-005111-51 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities.
There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).
In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling.
Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel.
Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.
This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications.
Further details are available at the link below.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Homozygous Familial Hypercholesterolemia HoFH
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REGENXBIO Inc.National Heart, Lung, and Blood Institute (NHLBI)TerminatedHomozygous Familial Hypercholesterolemia (HoFH)United States, Canada, Italy, Netherlands
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AstraZenecaCompletedHomozygous Familial Hypercholesterolemia (HoFH)Malaysia, Canada, Israel, Netherlands, Taiwan, Belgium, Denmark
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HDL TherapeuticsMedStar Heart and Vascular InstituteUnknownHomozygous Familial Hypercholesterolemia | HoFHUnited States
-
Amryt PharmaActive, not recruitingHomozygous Familial Hypercholesterolaemia (HoFH)Germany, Israel, Italy, Saudi Arabia, Spain, Tunisia
-
AstraZenecaCompletedHomozygous Familial Hypercholesterolemia (HoFH)Malaysia, Canada, Taiwan, Belgium, Denmark, Israel
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Organon and CoCompletedPrimary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
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REGENXBIO Inc.Active, not recruitingHomozygous Familial Hypercholesterolemia (HoFH)United States, Canada, Netherlands
-
REGENXBIO Inc.CompletedHomozygous Familial Hypercholesterolemia (HoFH)United States
-
Novartis PharmaceuticalsActive, not recruitingFamilial Hypercholesterolemia - HomozygousGreece, Lebanon, Turkey, France, Canada, Malaysia, Netherlands, United States
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Novartis PharmaceuticalsRecruitingHeterozygous or Homozygous Familial HypercholesterolemiaNetherlands, Israel, Hungary, Italy, Germany, Spain, France, Norway, South Africa, Turkey, United Kingdom, Canada, Switzerland, Brazil, Lebanon, Slovenia, United States, Russian Federation, Taiwan
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Hospital General Universitario Gregorio MarañonCompleted
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First Affiliated Hospital of Fujian Medical UniversityRecruiting
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AmgenCompletedMixed Dyslipidemia | Primary HypercholesterolemiaUnited States, Canada
-
Rigshospitalet, DenmarkWithdrawnLipid Lowering, Vascular InflammationDenmark
-
AmgenOrganization of Teratology Information Specialists (OTIS) Research Center...TerminatedHypercholesterolemia; ASCVD; Pregnancy
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AmgenCompletedMixed Dyslipidemia | Primary HypercholesterolemiaUnited States, Canada
-
First Affiliated Hospital Xi'an Jiaotong UniversityCompleted
-
AmgenTerminatedMixed Dyslipidemia | Primary HypercholesterolemiaChina
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LIB Therapeutics LLCCompletedHomozygous Familial HypercholesterolemiaUnited States, Israel, Norway, South Africa, Turkey, India
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University Hospital Inselspital, BerneAmgen; University of BernCompletedAcute Coronary SyndromeSwitzerland