Demystifying the L401 Protocol: Understanding Its Role in Clinical Trials

The world of clinical research can be complex, filled with specialized terminology and acronyms. One such term you might encounter is "L401 protocol." But what exactly does it signify?

Two Potential Meanings of L401 Protocol:

While a definitive answer depends on context, "L401 protocol" can potentially refer to two distinct concepts:

1. Internal Study Protocol:
   Within a specific pharmaceutical company or research institution, "L401" might be an internal designation for a particular clinical trial protocol. These internal codes often lack publicly available information.

2. Replicor Study Protocol REP 401:
   More likely, "L401 protocol" could be a shorthand reference to a specific clinical trial publicly documented as "Protocol REP 401." This trial, sponsored by Replicor, investigated the safety and efficacy of REP 2139 and REP 2165, medications designed to treat chronic hepatitis B infection.

Understanding REP 401: A Closer Look

If "L401 protocol" refers to REP 401, here's a breakdown of the study:

• Purpose: To evaluate the safety and effectiveness of REP 2139 and REP 2165 in combination with standard treatments for chronic hepatitis B infection.
• Design: Open-label, randomized, active-controlled, parallel comparison study. Participants were randomly assigned to receive either the investigational drugs combined with standard therapy or standard therapy alone.
• Outcomes: The study measured the ability of the investigational drugs to eliminate hepatitis B surface antigen (HBsAg), a key marker of the virus' presence.

Finding Information on REP 401:

For further details on REP 401, you can consult these resources:

• Replicor Website: While Replicor may no longer be actively developing these drugs, their website (http://replicor.com/) might still have archived information on REP 401, particularly the study protocol itself or clinical trial results if available.
• ClinicalTrials.gov: This U.S. government database (https://clinicaltrials.gov/) is a comprehensive resource for clinical research information. Search for "NCT02565719" (the unique identifier for REP 401) to access details about the study design, participant demographics, and potentially even the study results.

The Importance of Context:

Remember, the specific meaning of "L401 protocol" depends on the context in which you encounter it. If you're unsure, it's best to seek clarification from the source or conduct further research to determine the exact clinical trial it refers to.

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