An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension

NCT ID: NCT02882126

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2021-06-30

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subcutaneous Treprostinil

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.

Group Type: EXPERIMENTAL

Subcutaneous Treprostinil

Intervention Type: DRUG

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.

Interventions

Subcutaneous Treprostinil

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.

Intervention Type: DRUG

Other Intervention Names

Remodulin

Eligibility Criteria

Inclusion Criteria

A subject is eligible for inclusion in this study if all of the following criteria apply:

1. The subject voluntarily gives written informed consent to participate in the study.

2. The subject participated in and completed study CVT-CV-003.

3. 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.

4. 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.

5. 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:

1. The subject permanently discontinued Remodulin during study CVT-CV-003.

2. The subject is pregnant or lactating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CVie Therapeutics Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

United Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junbo Ge

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital affiliated with Fudan University

Locations

Beijing Chao-Yang Hospital

Beijing, , China

Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Fu Wai Hospital

Beijing, , China

Beijing Shijitan Hospital

Beijing, , China

Xiangya Hospital Centre South University

Changsha, , China

Guangdong General Hospital

Guangzhou, , China

Zhongshan Hospital affiliated with Fudan University

Shanghai, , China

Shanghai Pulmonary Hospital

Shanghai, , China

Wuhan Asia Heart Hospital

Wuhan, , China

Countries

China

Other Identifiers

CVT-CV-004

Identifier Type: -

Identifier Source: org_study_id