Charleston, SCNCT07227207Now EnrollingIRB Ready

Alpha-1 Antitrypsin Deficiency (AATD) Clinical Trial in Charleston, SC

Access cutting-edge alpha-1 antitrypsin deficiency (aatd) treatment through this clinical trial at a research site in Charleston. Study-provided care at no cost to qualified participants.

Sponsored by Tessera Therapeutics, Inc.

Quick Self-Assessment

See if you qualify for this Charleston location

Preparing your pre-screening questions…

Expert Care in Charleston

Access alpha-1 antitrypsin deficiency (aatd) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related alpha-1 antitrypsin deficiency (aatd) treatment provided free

Apply for This Charleston Location

Check if you qualify for this alpha-1 antitrypsin deficiency (aatd) clinical trial in Charleston, SC

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Charleston

    Convenient for SC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Charleston site if eligible
  4. 4Begin participation

About This Alpha-1 Antitrypsin Deficiency (AATD) Study in Charleston

This is a Phase 1/2, open-label, multi-center, dose escalation (Part 1), dose expansion (Part 2), and single repeat dose (Part 3) study to evaluate the safety, tolerability, efficacy, and PK/PD parameters of TSRA-196 in adults with the PiZZ genotype who have lung and/or liver disease associated with severe alpha-1 antitrypsin deficiency (AATD)

Sponsor: Tessera Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

Males or females who are 18 to 70 years of age, inclusive, at the time of signing the informed consent
Body mass index of 18 to 37 kg/m2, inclusive
Confirmed diagnosis of AATD and PiZZ genotype
At least one previous measure of blood total AAT level \<11 µmol/L
Nonsmoker for at least 6 months before screening and must remain nonsmoking for the entire study duration
Either AAT treatment-naïve or washed out of all investigational or approved treatments that modify AAT levels for 5 half-lives or at least 4 weeks, whichever is longer, before TSRA-196 administration Parts 1A and 2A (AATD lung disease with no or minimal liver fibrosis)
Clinically significant lung disease, defined as 1) evidence of emphysema or bronchiectasis by computed tomography or 2) DLCO \<70% of the predicted value or 3) ppFEV1 \<80%
ppFEV1 ≥35%
METAVIR fibrosis score F0 or F1 confirmed by liver biopsy at screening, or a liver stiffness measure by FibroScan ≤7 kPa at screening
FIB-4 index score ≤3.25 at screening
ALT and/or AST \<ULN at screening Parts 1B and 2B (AATD liver disease with significant or severe liver fibrosis, with or without AATD lung disease)
METAVIR fibrosis score F2 or F3 confirmed by liver biopsy at screening. A liver biopsy conducted within 12 months before screening is acceptable as a substitute.
Liver stiffness measure by FibroScan \>7 and ≤15 kPa at screening
ALT and/or AST \<2 x ULN at screening

Exclusion Criteria

Presence of genetic variation in SERPINA1 gene that may disrupt the function of TSRA-196, determined by screening genotyping
History of liver disease unrelated to AATD, or history of or clinical signs of cirrhosis
Significant lung disease not attributable to manifestations of AATD, as determined by the investigator
History of one or more hospitalizations due to severe exacerbation of underlying lung disease during the year before screening or received IV antibiotics for treatment of a pulmonary infection within 6 months before screening
Unstable AATD-related COPD, as determined by the investigator, or severe bronchiectasis
Lung volume reduction surgery within 1 year before screening or plan to receive lung volume reduction surgery during the study period
Documented chronic need for positive airway pressure therapy beyond nocturnal use
Seropositive for human immunodeficiency virus (HIV) (HIV-1 or HIV-2)
Seropositive for hepatitis B (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\] positive) with detectable HBV DNA
Hepatitis C virus (HCV) RNA positive at screening (Parts 1A and 2A), or HCV RNA positive and/or HCV antibody positive at screening (Parts 1B and 2B)
Has received an organ transplant or is on a waiting list for an organ transplant
Prior treatment with gene therapy using viral vectors or intended to permanently change the patient's DNA
Any investigational products within 30 days before dosing or plan to take an investigational product before the end of study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charleston?

Yes, this clinical trial (NCT07227207) has an active research site in Charleston, SC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alpha-1 Antitrypsin Deficiency (AATD) Treatment Options in Charleston, SC

If you're searching for alpha-1 antitrypsin deficiency (aatd) treatment options in Charleston, SC, this clinical trial (NCT07227207) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charleston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced alpha-1 antitrypsin deficiency (aatd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alpha-1 antitrypsin deficiency (aatd) clinical trials near you to find additional studies recruiting in your area.

More Pulmonary Hypertension Trials in Charleston, SC

See all pulmonary hypertension clinical trials recruiting in Charleston — not just this study.

Browse Pulmonary Hypertension Trials in Charleston →

Browse More Trials by Condition

Pulmonary Hypertension TrialsAlpha-1 Antitrypsin Deficiency TrialsInterstitial Cystitis TrialsTardive Dyskinesia TrialsAll Conditions →

Ready to Join in Charleston?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Charleston, SC