Join the PLEDGE Study

This study is open to adults diagnosed with PNH who are taking VOYDEYA™ (danicopan) or will start taking it soon as an add-on to the complement inhibitors ULTOMIRIS® (ravulizumab) or SOLIRIS (eculizumab).

The de-identified data gathered from the surveys and medical records is helpful for researchers to understand real-world disease and treatment experiences of patients with PNH.

Joining this study is completely optional. If you choose not to participate, your medical care, including your Alexion treatment and OneSource enrollment, will stay the same.

This is not a clinical trial. A traditional clinical trial involves testing a specific treatment, like a drug or medical device. The PLEDGE Study will only review de-identified survey answers and data from medical records produced during your visits to the doctor – in other words, there are no additional labs, tests, or appointments required for you to participate. 

Yes. You will be asked to complete online paid surveys as part of the study once you sign up and again two weeks, two months, and six months after initiating treatment. It’s important you complete these surveys in a timely manner as they are intended to assess the impact of VOYDEYA™ (danicopan) on your condition. 

No, there is no cost to participate as you’ll receive PicnicHealth’s service free of charge as part of your participation in the PLEDGE Study. If you would like to continue to have PicnicHealth collect your medical records, you may sign-up in the service as a customer at the end of the PLEDGE Study or if you are not eligible for the PLEDGE Study, you may opt to sign-up for a paid subscription.

Yes, you can withdraw your consent at any time. This will not affect your medical care, future study participation, or OneSource enrollment. When you withdraw, PicnicHealth will stop collecting your records, but any data collected before will remain in the study. 

For details about withdrawing your study consent, including details about the surveys and data collection, please reach out to PicnicHealth at help@picnichealth.com or call (415) 680-3085.

PicnicHealth is a leading health technology company simplifying healthcare for everyone. Through a combination of clinical expertise and technology, PicnicHealth provides patients with their organized medical records to prepare for doctor visits and advocate for themselves. Patients can also more easily participate in observational research to advance medicine and enrich lives.

Alexion is the research sponsor of the PLEDGE Study. Alexion has engaged PicnicHealth, a digital health company, to administer the surveys and securely collect and manage study participants’ medical records for the purpose of this study.

Alexion has engaged PicnicHealth to help researchers collect and manage medical records in order to learn more about how PNH affects adults in the real world. When you sign up for the PicnicHealth application, PicnicHealth will do all the work of collecting, digitizing, and organizing your medical records, regardless of where you have received care. No effort is required on your part to obtain your medical records

You will then get access to a secure online platform for you to view and share your organized records. To protect your privacy, information that directly identifies you will be removed, and a unique code will be assigned to your medical records (de-identified) before sharing with Alexion for the purpose of this study. The information gathered from patient medical records is helpful for researchers to understand real world disease and treatment experiences patients with PNH have. 

We’ll start by searching for any of your records through our connected network. If necessary, direct requests can also be sent to your healthcare providers. Electronic records can be available within an hour, while records from individual providers may take a couple of weeks.

PicnicHealth will never share your records without your explicit consent. By signing up for this study, you're agreeing to share your de-identified data with the Alexion study team. No one outside PicnicHealth - including your doctor or insurance company - will be able to see your medical records unless you choose to share them by clicking "Send Records" at the top of your PicnicHealth timeline.

PicnicHealth follows Health Insurance Portability and Accountability Act (HIPAA)-compliant practices and uses advanced end-to-end encryption and security measures, the same technology banks use to keep information secure. Your records are only shared with your permission.

For more details or assistance regarding the PicnicHealth platform and medical record services, visit our website or reach out to the PicnicHealth team at hello@picnichealth.com.