Back to resultsAn Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension
Primary Purpose
Pulmonary Arterial Hypertension
Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Subcutaneous Treprostinil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring PAH, Subcutaneous Treprostinil, Remodulin, 6 Minute Walk Test
Eligibility Criteria
Inclusion Criteria:
A subject is eligible for inclusion in this study if all of the following criteria apply:
- The subject voluntarily gives written informed consent to participate in the study.
- The subject participated in and completed study CVT-CV-003.
Sexually active women of childbearing potential must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two different forms of highly effective contraception. Medically acceptable forms of effective contraception include: (1) approved hormonal contraceptive (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device (IUD), or (4) partner vasectomy. Women of child bearing potential include any females who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not postmenopausal (defined as amenorrhea for at least 12 consecutive months).
Males participating in the study must use a condom during the length of the study, and for at least 48 hours after discontinuing study medication.
- The subject has not developed a concurrent illness or condition during the conduct of the previous study (including but not restricted to, sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension or left sided heart disease) that would make participation in this study detrimental to the subject's health in the opinion of the Investigator.
- In the opinion of the Principal Investigator, the subject is able to communicate effectively with study personnel, is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits, and is mentally and physically capable of administering Remodulin by continuous SC infusion using a micro infusion pump.
Exclusion Criteria:
A subject is not eligible for inclusion in this study if any of the following criteria apply:
- The subject permanently discontinued Remodulin during study CVT-CV-003.
- The subject is pregnant or lactating.
Sites / Locations
- Beijing Chao-Yang Hospital
- Beijing Anzhen Hospital, Capital Medical University
- Peking Union Medical College Hospital
- Fu Wai Hospital
- Beijing Shijitan Hospital
- Xiangya Hospital Centre South University
- Guangdong General Hospital
- Zhongshan Hospital affiliated with Fudan University
- Shanghai Pulmonary Hospital
- Wuhan Asia Heart Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subcutaneous Treprostinil
Arm Description
Open-label access; The initial dose of Remodulin for this study will be the same as each subject's final dose in study CVT-CV-003. Dose modification will be based according to clinical response and tolerability.
Outcomes
Primary Outcome Measures
Incidence of Adverse Events Among Subjects through Study Completion
Adverse events among participants will be recorded throughout participation in the study. The incidence of adverse events among subjects through study completion, an average of 3 years, will be described by the number of subjects analyzed and the percentage of those subjects who experienced an adverse event until study completion.
Change in 6-minute Walk Distance (6MWD) From Baseline to Month 12
The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Month 12, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.
Change in Borg Dyspnea Score (following 6MWT) from Baseline to Month 12
The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score will be assessed immediately following the 6MWT. Scores range from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced). Changes from Baseline to Month 12 will be summarized and compared between treatment groups using descriptive statistics. No formal hypothesis testing will be performed.
Number of Participants with a Change from Baseline World Health Organization (WHO) Functional Classification at Month 12
The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. Changes from Baseline to Month 12 will be summarized and compared between treatment groups using descriptive statistics. No formal hypothesis testing will be performed.
Secondary Outcome Measures
Full Information
NCT ID
NCT02882126
First Posted
August 24, 2016
Last Updated
May 8, 2017
Sponsor
United Therapeutics
Collaborators
CVie Therapeutics Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02882126
Brief Title
An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension
Official Title
An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics
Collaborators
CVie Therapeutics Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, open-label trial to evaluate the safety of continued therapy with subcutaneous Remodulin® in subjects with pulmonary arterial hypertension (PAH) who complete the CVT-CV-003 study. The study will include about 50 subjects at up to 10 clinical trial centers in China who completed all required assessments in the CVT-CV-003 study. Study visits for data collection will occur at month 6 and 12 with yearly visits beyond 12 months until the study is discontinued by the sponsor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
PAH, Subcutaneous Treprostinil, Remodulin, 6 Minute Walk Test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subcutaneous Treprostinil
Arm Type
Experimental
Arm Description
Open-label access; The initial dose of Remodulin for this study will be the same as each subject's final dose in study CVT-CV-003. Dose modification will be based according to clinical response and tolerability.
Intervention Type
Drug
Intervention Name(s)
Subcutaneous Treprostinil
Other Intervention Name(s)
Remodulin
Intervention Description
Remodulin (1.0, 2.5, 5 and 10 mg/ml formulations as available) will be administered by continuous subcutaneous infusion via a subcutaneous cannula using a microbore infusion tubing set and a micro infusion pump.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events Among Subjects through Study Completion
Description
Adverse events among participants will be recorded throughout participation in the study. The incidence of adverse events among subjects through study completion, an average of 3 years, will be described by the number of subjects analyzed and the percentage of those subjects who experienced an adverse event until study completion.
Time Frame
Study Completion, an Average of 3 Years
Title
Change in 6-minute Walk Distance (6MWD) From Baseline to Month 12
Description
The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Month 12, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.
Time Frame
Baseline and Month 12
Title
Change in Borg Dyspnea Score (following 6MWT) from Baseline to Month 12
Description
The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score will be assessed immediately following the 6MWT. Scores range from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced). Changes from Baseline to Month 12 will be summarized and compared between treatment groups using descriptive statistics. No formal hypothesis testing will be performed.
Time Frame
Baseline and Month 12
Title
Number of Participants with a Change from Baseline World Health Organization (WHO) Functional Classification at Month 12
Description
The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. Changes from Baseline to Month 12 will be summarized and compared between treatment groups using descriptive statistics. No formal hypothesis testing will be performed.
Time Frame
Change from Baseline at Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A subject is eligible for inclusion in this study if all of the following criteria apply:
The subject voluntarily gives written informed consent to participate in the study.
The subject participated in and completed study CVT-CV-003.
Sexually active women of childbearing potential must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two different forms of highly effective contraception. Medically acceptable forms of effective contraception include: (1) approved hormonal contraceptive (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device (IUD), or (4) partner vasectomy. Women of child bearing potential include any females who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not postmenopausal (defined as amenorrhea for at least 12 consecutive months).
Males participating in the study must use a condom during the length of the study, and for at least 48 hours after discontinuing study medication.
The subject has not developed a concurrent illness or condition during the conduct of the previous study (including but not restricted to, sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension or left sided heart disease) that would make participation in this study detrimental to the subject's health in the opinion of the Investigator.
In the opinion of the Principal Investigator, the subject is able to communicate effectively with study personnel, is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits, and is mentally and physically capable of administering Remodulin by continuous SC infusion using a micro infusion pump.
Exclusion Criteria:
A subject is not eligible for inclusion in this study if any of the following criteria apply:
The subject permanently discontinued Remodulin during study CVT-CV-003.
The subject is pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge
Organizational Affiliation
Zhongshan Hospital affiliated with Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Fu Wai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Beijing Shijitan Hospital
City
Beijing
ZIP/Postal Code
100038
Country
China
Facility Name
Xiangya Hospital Centre South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Zhongshan Hospital affiliated with Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
12. IPD Sharing Statement
Learn more about this trial
An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension
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