Pulmonary Arterial HypertensionPhase 4NCT02882126
An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension
A Phase 4 study testing Subcutaneous Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Subcutaneous Treprostinil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesChina
- Study dates
- Jun 2017to Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing Chao-Yang Hospital
Beijing, 100020
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Peking Union Medical College Hospital
Beijing, 100032
Fu Wai Hospital
Beijing, 100037
Beijing Shijitan Hospital
Beijing, 100038
Xiangya Hospital Centre South University
Changsha, 410008
Guangdong General Hospital
Guangzhou, 510080
Zhongshan Hospital affiliated with Fudan University
Shanghai, 200032
Shanghai Pulmonary Hospital
Shanghai, 200433
Wuhan Asia Heart Hospital
Wuhan, 430022
About this study
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
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Subcutaneous Treprostinil
- Keywords
- PAH, Subcutaneous Treprostinil, Remodulin, 6 Minute Walk Test
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous TreprostinilDrug
Also called Remodulin
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.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Treprostinil | Experimental | 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. Receives: Drug: Subcutaneous Treprostinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study Completion, an Average of 3 Years
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.
Measured: Baseline and Month 12
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.
Measured: Baseline and Month 12
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.
Measured: Change from Baseline at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJun 2017 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CVie Therapeutics Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Principal investigator, Zhongshan Hospital affiliated with Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882126
- Sponsor's protocol ID
- CVT-CV-004
- Status last verified
- May 2017
- First submitted
- 24 Aug 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02882126
- Acronym / sponsor ID
- CVT-CV-004
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH, Subcutaneous Treprostinil, Remodulin, 6 Minute Walk Test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- CVie Therapeutics Co. Ltd.
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Treprostinil | Experimental | Drug: Subcutaneous TreprostinilOpen-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous TreprostinilAlso: RemodulinRemodulin (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. | Drug | Subcutaneous Treprostinil |
Primary outcome
Incidence of Adverse Events Among Subjects through Study Completion
Time frame: Study Completion, an Average of 3 Years
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
Time frame: Baseline and 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
Time frame: Baseline and 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
Time frame: Change from Baseline 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge principal investigator
Zhongshan Hospital affiliated with Fudan University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Subcutaneous Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events Among Subjects through Study Completion (time frame: Study Completion, an Average of 3 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.