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Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia (RAMAN)

Primary Purpose

Homozygous Familial Hypercholesterolemia HoFH

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
evolocumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Homozygous Familial Hypercholesterolemia HoFH focused on measuring Evolocumab, Hypercholesterolemia

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evolocumab

Arm Description

Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.

Secondary Outcome Measures

Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)
Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
Percent Change From Baseline to Week 12 in Lipoprotein(a) (Lp[a])

Full Information

First Posted
January 3, 2018
Last Updated
November 13, 2020
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03403374
Brief Title
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
Acronym
RAMAN
Official Title
A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 4, 2018 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Homozygous Familial Hypercholesterolemia HoFH
Keywords
Evolocumab, Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab
Arm Type
Experimental
Arm Description
Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).
Intervention Type
Drug
Intervention Name(s)
evolocumab
Other Intervention Name(s)
Repatha®, EvoMab
Intervention Description
Administered by SC injection via autoinjector (AI)/pen
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame
baseline, week 12
Title
Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
Time Frame
baseline, week 12
Title
Percent Change From Baseline to Week 12 in Lipoprotein(a) (Lp[a])
Time Frame
baseline, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 002
Country
India
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 029
Country
India
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 060
Country
India
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 062
Country
India
Facility Name
Research Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 054
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 017
Country
India
Facility Name
Research Site
City
Belagavi
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
Research Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682 027
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 007
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 005
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 006
Country
India
Facility Name
Research Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226 003
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.amgen.com/datasharing
Citations:
PubMed Identifier
34750081
Citation
Bansal S, Ruzza A, Sawhney J, Kulkarni G, Iyengar S, Mehta V, Hamer A, Wu Y, Raal FJ. Evolocumab in patients with homozygous familial hypercholesterolemia in India. J Clin Lipidol. 2021 Nov-Dec;15(6):814-821. doi: 10.1016/j.jacl.2021.10.003. Epub 2021 Oct 20.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia

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